INSTRUCTIONS FOR USE FOR BAUSCH + LOMB SOFT CONTACT LENSES

Congratulations on joining millions of others around the world who enjoy wearing Bausch + Lomb contact lenses. The information in this instruction for use (IFU) is intended for users of Bausch + Lomb soft contact lenses; it includes important product use and safety information. It is essential that users follow these instructions and the directions from your eye care practitioner (ECP) for protection of your vision and eye health. If you have questions on the information contained within this IFU, consult your ECP. These instructions for use apply to the following products:


Table: The Contact Lens Products That This IFU Applies To:

PRODUCT/MATERIAL NAME WATER CONTENT PACKAGING SOLUTION WEARING SCHEDULE REPLACEMENT PERIOD
INDICATION (by weight %)
-Iconnect OxyRich Spherical or Therapeutic Use Borate buffered saline
(balafilcon A) Visibility Tinted Contact Lenses Daily wear or extended wear for 1 to 30 days between removal Replace lenses every 30 days or as prescribed by the ECP
PureVision®2 (balafilcon A) Visibility Tinted Contact Lenses Spherical or Therapeutic Use 36% Borate buffered saline with poloxamine
PureVision®2 For Astigmatism (balafilcon A) Visibility Tinted Contact Lenses Astigmatism or Therapeutic Use
PureVision®2 For Presbyopia (balafilcon A) Visibility Tinted Contact Lenses Presbyopia or Therapeutic Use
SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses Astigmatism 66% Daily wear or extended Replace lenses every 30 days or as prescribed by the ECP
Borate buffered saline wear for 1 to 7 days between removal
(polymacon) Contact Lenses – B4, U4 and H04 Spherical 61.4% poly(2-hydroxyethyl-methacrylate), in sterilized solution of phosphate buffered saline with 0.1% polyvinyl alcohol
Daily wear Recommended replacement after 8-9 months or as prescribed by the ECP
(polymacon) Contact Lenses Optima 38 38.60% 61.4% poly(2-hydroxyethyl-methacrylate), in sterilized solution of phosphate buffered saline with 0.9%. sodium chloride
SofLens® Multi-Focal (polymacon) Visibility Tinted Contact Lenses Presbyopia Phosphate buffered saline with 0.1% polyvinyl alcohol.For Lacelle Borate buffered saline Daily wear or extended
Lacelle® Natural Look (polymacon) Opaque Tinted Contact Lenses Spherical
Bausch + Lomb Ultra® (samfilcon A) Visibility Tinted Soft Contact Lenses Spherical 46% Borate buffered saline with poloxamine. Daily wear or extended Replace lenses every 30 days or as prescribed by the ECP
Bausch + Lomb Ultra® for Astigmatism (samfilcon A) Visibility Tinted Soft Contact Lenses Astigmatism
Iconnect (hilafilcon B) Visibility Tinted Contact Lenses Spherical
SofLens® 59 (hilafilcon B) Visibility Tinted Contact Lenses Spherical 59% Borate buffered saline Daily wear or extended Replace lenses every 30 days or as prescribed by the EC
Medivision (hilafilcon B) Visibility Tinted Contact Lenses Spherical
Bausch+Lomb LACELLE Premium Spherical 38% Buffered saline solution.
Bausch+Lomb LACELLE CIRCLE


HOW THE LENS WORKS (ACTIONS)

The contact lenses in Table 1 transmit between 86% to 98% visible light. When placed on the cornea in their hydrated state, all the contact lenses listed in Table 1 act as a refracting medium to focus light rays on the retina. When the Purevision®, iconnect OxyRich and Purevision®2 contact lens products, intended for therapeutic use, are placed on the cornea they also act as a bandage to protect the cornea and relieve pain during treatment of ocular pathologies.


INDICATIONS AND INTENDED USES

Spherical: The Bausch + Lomb soft contact lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity.

Astigmatism: The Bausch + Lomb soft contact lens is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 diopters or less, that does not interfere with visual acuity.

Presbyopia: The Bausch + Lomb soft contact lens is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity.

Presbyopia and Astigmatism: The Bausch + Lomb soft contact lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters and require an add power ranging from +0.75D to +5.00D.

Therapeutic use: The Bausch + Lomb PureVision® and PureVision®2 (balafilcon A) contact lenses can also be used for therapeutic use in the management of corneal epithelial disorders. When reusing the contact lenses, they must be cleaned, rinsed, and disinfected between removal and reinsertion. Always follow your ECP’s recommended wear schedule and replacement periods. Refer to Table 1 for information on the wearing schedule and replacement period for the contact lens products.

Note: Aphakic means‘lacking a focusing lens inside the eye’.


CONTRAINDICATIONS (REASONS NOT TO USE)

DO NOT USE Bausch + Lomb contact lenses when any of the following conditions exist:

  • Allergy, inflammation, infection, irritation, or redness in or around the eye
  • Dry eyes (inadequate tear fluid)
  • Any eye disease, injury (e.g., corneal abrasion), or abnormality that affects the cornea, conjunctiva, or eyelids
  • Reduced corneal sensitivity
  • Any systemic disease or poor health (e.g., colds or flu), that may affect the eye or be exaggerated by wearing contact lenses
  • Allergic reaction of ocular surfaces or surrounding tissue that may be induced or exaggerated by wearing contact lenses
  • Allergy to any ingredient in a solution used to care for Bausch + Lomb contact lenses
  • Any active corneal infection (bacterial, fungal, or viral)
  • Patients unwilling or unable to understand or comply with any warnings, precautions, restrictions, or directions
  • Use of medications that are contraindicated for contact lens wear
  • Any previous medical intervention which may adversely affect the use of the device

WARNINGS

Problems with contact lenses could result in serious injury to your eye or in serious eye infections, including infectious keratitis. It is essential that you follow your ECP’s directions and all labeling instructions for proper use of the lenses. You should be aware of and fully discuss with your ECP the following warnings:

  • Strict compliance with your wearing restrictions, wearing schedule, replacement period, cleaning regimen, and follow-up visit schedule should be followed. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision (including blindness).
  • Daily wear lenses are not indicated for overnight wear and should not be worn while sleeping. Clinical studies have shown that the risk of serious adverse reactions is increased when daily wear lenses are worn overnight.
  • Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers.
  • Re-use of single-use daily disposable lenses could lead to lens changes that may cause discomfort and poor visual acuity.
  • If you experience eye discomfort, excessive tearing, vision changes, or redness of the eye, you should immediately remove lenses and promptly contact your ECP.
  • DO NOT use if the package is damaged or unintentionally opened.
  • DO NOT expose contact lenses to non-sterile water (e.g., tap water) while wearing them.Water can harbor microorganisms that can lead to severe infection and loss of vision (including blindness). If your lenses have been submersed in water when swimming in pools, lakes, or oceans, discard them and replace them with a new pair.

EXTENDED WEAR

  • The risk of infection (infectious keratitis) has been shown to be greater among users of extended wear contact lenses than among users of daily wear contact lenses.
  • Some researchers believe that complications are caused by one or more of the following: a weakening of the cornea’s resistance to infections, particularly during a closed-eye condition, as a result of hypoxia; an eye environment which is somewhat more conducive to the growth of bacteria and other microorganisms, particularly when a regular periodic lens removal and disinfecting or disposal schedule has not been adhered to by the patient; improper lens disinfection or cleaning by the patient; contamination of lens care products; poor personal hygiene by the patient; patient unsuitability to the particular lens or wearing schedule; accumulation of lens deposits; damage to the lens; improper fitting; length of wearing time; and the presence of ocular debris or environmental contaminants.
  • While the great majority of patients successfully wear contact lenses, extended wear of lenses is also reported to be associated with a higher incidence and degree of epithelial microcysts and infiltrates, and endothelial polymegathism, which require consideration of discontinuation or restriction of extended wear. The epithelial conditions are reversible upon discontinuation of extended wear.
  • The reversibility of endothelial effects of contact lens wear has not been conclusively established. As a result, ECPs’views of extended wearing times vary from not prescribing extended wear at all to prescribing flexible wearing times from occasional overnight wear to prescribing specified wearing periods, with follow-up visits and a proper care regimen.

PRECAUTIONS

You should be aware of and fully discuss with your ECP the following safety precautions:

  • Before leaving your ECP’s office, be certain that you can remove your lenses promptly or have someone else available to remove them for you.
  • Never wear your lenses beyond the period recommended by your ECP.
  • Always wash and rinse hands before handling lenses. DO NOT get cosmetics, lotions, soaps, creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses before putting on makeup. Water-based cosmetics are less likely to damage lenses than oil-based products.
  • Be certain that fingers and hands are free of foreign materials before touching your lenses, as microscopic scratches on the lenses may occur, causing distorted vision and/or injury to the eye.
  • Always handle your lenses carefully and avoid dropping them.
  • DO NOT touch the lenses with your fingernails.
  • Carefully follow the instructions in this leaflet and those recommended by your ECP for handling, insertion, removal, cleaning, storing, and wearing of contact lenses.
  • Never use tweezers or other tools to remove your lenses from the lens container unless specifically indicated for that use. Pour the lens into the hand.
  • If the lens sticks (stops moving) on the eye, follow the recommended directions in CARE FOR A STICKING (NON-MOVING) LENS. If non-movement of the lens continues, you should immediately consult your ECP.
  • Avoid, if possible, all harmful or irritating vapors and fumes when wearing lenses.
  • If your contact lenses come into contact with noxious vapor (e.g., chemical or hazardous substances), or a hazardous environment with ocular impact, they should be removed immediately.
  • DO NOT freeze.
  • DO NOT share your lenses with others. In addition, for therapeutic use:
  • Close ECP supervision is necessary for the therapeutic use of the PureVision® and PureVision®2 (balafilcon A) contact lenses.
  • Medications necessary for treatment should be used with caution and under close supervision by the ECP.
  • In some circumstances only, the ECP will insert and remove lenses. If so, patients should be instructed NOT to handle the lenses themselves.

LENS CARE PRECAUTIONS

  • Always use fresh, unexpired lens care solutions recommended by your ECP.
  • Always follow directions in the package inserts for the use of contact lens solutions.
  • Always keep the lenses completely immersed in the recommended storage solution when lenses are not being worn (stored). Follow the lens care directions for CARE FOR A DRIED OUT (DEHYDRATED) LENS if lens surface does become dried out.
  • DO NOT use saliva or anything other than the recommended solution for lubricating or wetting lenses.
  • Never use conventional hard contact lens solutions that are not also recommended for use with prescribed lenses.
  • DO NOT mix or alternate lens care systems or solutions unless indicated in the lens care system labeling or without consulting your ECP.
  • DO NOT use the Ultracare Disinfecting System or any of its components (Ultracare Disinfecting Solution, Ultracare Neutralizing Tablets, Lens Plus Daily Cleaner, and Ultrazyme Enzymatic Cleaner) to clean and disinfect the PureVision® or PureVision®2 (balafilcon A) lenses because the lens dimensions will be altered.

ADVERSE REACTIONS (PROBLEMS AND WHAT TO DO)

You should be aware that the following problems may occur:

  • Eyes stinging, burning, itching (irritation), or other eye pain
  • Comfort is less than when lens was first placed on eye
  • Abnormal feeling of something in the eye (e.g., foreign body, scratched area)
  • Excessive watering (tearing) of the eyes or unusual eye secretions
  • Redness of the eyes
  • Reduced sharpness of vision (poor visual acuity)
  • Blurred vision, rainbows, or halos around objects
  • Sensitivity to light (photophobia)
  • Dry eyes

If you notice any of the above, you should IMMEDIATELY REMOVE YOUR LENSES.

  • If the discomfort or problem stops, then look closely at the lens. If the lens is in any way damaged, DO NOT put the lens back on your eye. You should discard the lens and insert a new lens. If the problem continues, you should immediately remove the lens and consult your ECP.
  • When any of the above problems occur, a serious condition such as infection, corneal ulcer, neovascularization, or iritis may be present. You should keep the lens off your eye and seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage.
  • During therapeutic use, an adverse reaction may be due to the original disease or injury or may be because of wearing a contact lens. There is a possibility that the existing disease or condition might become worse when a soft contact lens for therapeutic use is used to treat an already diseased or damaged eye. If there is any increase in symptoms while wearing the lens, immediately contact your ECP.

TOPICS TO DISCUSS WITH YOUR EYE CARE PRACTITIONER

As with any contact lens, follow-up visits are necessary to assure the continuing health of the eyes. You should be instructed as to a recommended follow-up schedule. Patients are advised to consult with their ECP prior to:

  • Wearing lenses during sporting and water-related activities. Exposure to water while wearing contact lenses in activities such as swimming, water skiing, and hot tubs may increase the risk of ocular infection including, but not limited to, Acanthamoeba keratitis.
  • Changing the lens type or lens parameter.
  • Using any medicine in the eyes. Medications, such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, and those for motion sickness may cause dryness of the eye, increased lens awareness, or blurred vision. Should such conditions exist, proper remedial measures should be prescribed. Depending on the severity, this could include the use of rewetting drops that are indicated for use with soft contact lenses or temporary discontinuance of contact lens wear while such medication is being used.
  • Oral contraceptive users could develop visual changes or changes in lens tolerance when using contact lenses. Patients should be cautioned by the ECP accordingly.
  • Wearing contact lenses when in excessively dry or dusty environments.
  • Contact your ECP if you have not worn contact lenses for a prolonged length of time.
  • Contact your ECP regarding any additional wearing restrictions that apply to you.

WHO SHOULD KNOW THAT YOU ARE WEARING CONTACT LENSES

  • Inform your doctor (health care practitioner) about being a contact lens wearer.
  • Always inform your employer of being a contact lens wearer. Some jobs may require the use of eye protection equipment or may require that you DO NOT wear contact lenses.

PERSONAL CLEANLINESS AND LENS HANDLING

PREPARING THE LENS FOR WEARING

  • Always wash your hands thoroughly with a mild soap, rinse completely, and dry with a lint-free towel before touching your lenses.
  • Avoid the use of soaps containing cold cream, lotion, or oily cosmetics before handling your lenses, since these substances may come into contact with the lenses and interfere with successful wearing.
  • Handle your lenses with your fingertips and be careful to avoid contact with fingernails. It is helpful to keep your fingernails short and smooth.

HANDLING THE LENSES

  • Always insert and remove the same lens first to avoid mix-ups.
  • Position the lens on your index finger and examine the lens to be sure that it is moist, clean, clear, and free of any nicks or tears. Make sure the lens is the right way out.
  • Should you accidentally place an inside-out lens on your eye, one of the following signs should signal you to remove and replace it correctly:
    • Less than usual comfort
    • The lens may fold on the eye
    • Excessive lens movement on blink o Blurred vision
  • If the lens folds and sticks together, place the lens in the palm of your hand and wet thoroughly with the rewetting solution recommended by your ECP. Then GENTLY rub the lens between your index finger and palm in a back and forth motion.
  • If the lens flattens or drapes across your finger, the lens or your finger may be too wet. To correct this, dry your finger by transferring the lens several times from one index finger to the other, drying the opposite finger each time.
  • Never place a lens on the eye unless it has been fully hydrated (wet) with the rinsing or storing solution recommended by your ECP.

PLACING THE LENS ON THE EYE:

The One Hand Placement Technique

Place the lens on your index finger. With your head up, looking straight ahead, pull down your lower eyelid with the middle finger of your placement hand. Look up steadily at a point above you. Then place the lens on the lower white part of your eye. Remove your index finger and slowly release the lower eyelid. Look down to position the lens properly. Close your eyes for a moment and the lens should center itself on your eye.

The Two Hand Placement Technique

With the lens on your index finger, use the middle finger of the other hand to pull the upper eyelid against the brow. Use the middle finger of your placement hand to pull down the lower eyelid and then place the lens centrally on your eye. While holding this position, look downward to position the lens properly. Slowly release your eyelids.

If the lens feels uncomfortable, then:

Look in a mirror and gently place a finger on the edge of the contact lens and slowly slide the lens away from your nose while looking in the opposite direction. Then by blinking, the lens will recenter itself. If the lens still feels uncomfortable, follow the steps described in ADVERSE REACTIONS (PROBLEMS AND WHAT TO DO).


CENTERING THE LENS

If after placement of the lens your vision is blurred, check for the following:

  • The lens is not centered on the eye. To center a lens, follow one of the procedures below:
    • Hold the upper and lower eyelids open with your fingers. Then, while looking in a mirror, gently place a finger on the contact lens and slide the lens towards the center of the eye.
    • OR

    • Hold the upper and lower eyelids open with your fingers. Then, while looking in a mirror, move your eye towards the lens to place it on the center of the eye.
  • If the lens is centered, remove the lens and check for the following:
    • Cosmetics or oils on the lens. Clean, rinse, disinfect, and place on the eye again. o The lens is on the wrong eye.
    • The lens is inside-out (it would not be as comfortable as normal).

If you find that your vision is still blurred after checking the above, remove both lenses and consult your ECP.


REMOVING THE LENS

  • Always remove the same lens first.
  • Wash, rinse, and dry your hands thoroughly.
  • Always be sure that the lens is in the correct position on your eye before you try to remove it (a simple check of your vision, closing one eye at a time, will tell you if the lens is in the correct position). Look up and slowly pull down your lower eyelid with the middle finger of your removal hand and place your index finger on the lower edge of the lens. Squeeze the lens lightly between the thumb and index finger and remove it. Avoid sticking the edges of the lens together.
  • Remove the other lens by following the same procedure.
  • Use rewetting drops recommended by your ECP if lens is difficult to remove.
  • Follow the required lens care procedures described in CARING FOR YOUR LENSES.
  • Note: If this method of removing your lens is difficult for you, your ECP will provide you with an alternative method.


CARE FOR A STICKING (NON-MOVING) LENS

If a lens sticks (stops moving), put a few drops of the rewetting solution recommended by your ECP into your eye. In this case, DO NOT use plain water or anything other than the recommended solutions. DO NOT attempt to remove a lens that is sticking, which could damage your eye. If the lens does not begin to move when you blink after several applications of the solution, immediately contact your ECP. DO NOT attempt to remove the lens except on the advice of your ECP.


LENS WEARING SCHEDULES

Your ECP may either recommend using contact lenses as a disposable lens or a frequent/planned replacement lens. Regardless of the schedule prescribed for you, once a lens is removed at the end of the prescribed wearing period, your eye should have a rest period with no lens wear of overnight or longer, as recommended by your ECP.

Daily Wear
There may be a tendency for the daily wear patient to over wear the lenses initially. The wearing schedule should be determined by the ECP and provided to the patient.

Extended Wear (Greater Than 24 Hours or While Asleep)
Bausch + Lomb recommends the contact lens wearer first be evaluated on a daily wear schedule. If successful, then gradual introduction of extended wear can be followed, as determined by the ECP. These lenses have been approved for extended wear for up to 7 days or up to 30 days depending on the product. The lens must be removed, cleaned, and disinfected, or disposed of and replaced with a new lens, as determined by the ECP. Once removed, a lens should remain out of the eye for a period of rest overnight or longer, as determined by the ECP.

Disposable Lens Wear
No lens care is needed. The lenses are discarded every time they are removed from the eye. The lenses should only be cleaned, rinsed, and disinfected on an emergency basis when replacement lenses are not available.

Frequent/Planned Replacement
When removed between replacement periods, lenses must be cleaned and disinfected before reinsertion, or be discarded and replaced with a new lens, as determined by the ECP.


CARING FOR YOUR LENSES

  • For continued safe and comfortable wearing of your lenses, it is important that you first clean and rinse, then disinfect [and neutralize (for hydrogen peroxide systems)] your lenses after each removal, using the lens care regimen recommended by your ECP.
  • Failure to follow the recommended lens care regimen may result in development of serious ocular complications.

SOAKING AND STORING LENSES

Instructions for Use:

Use only fresh contact lens disinfecting solution each time you soak (store) your lenses.

WARNING:

  • DO NOT re-use or“top-off”old solution left in lens case since solution re-use reduces effective lens disinfection and could lead to severe infection, vision loss (including blindness).“Topping-off”is the addition of fresh solution to solution that has been sitting in the case.

RUB AND RINSE TIME

Instructions for Use:

Follow the complete recommended lens rubbing and rinsing times in the labeling of the solution used for cleaning, disinfecting, and soaking lenses to adequately disinfect lenses and reduce the risk of contact lens infection.

WARNING:

  • Rub and rinse lenses for the recommended amount of time to help prevent serious eye infections.
  • Never use water, saline solution, or rewetting drops to disinfect lenses. These solutions will not disinfect lenses. Not using the recommended disinfectant can lead to serious infection, vision loss (including blindness).

LENS CASE CARE

Instructions for Use:

  • Clean contact lens cases with finger rubbing using fresh, sterile disinfecting solution/contact lens cleaner. Never use water. Cleaning should be followed by rinsing with fresh, sterile disinfecting solutions and wiping the lens cases with fresh, clean, lint-free tissue is recommended. Never air-dry or recap the lens case lids after use without any additional cleaning methods. If air-drying, be sure that no residual solution remains in the case before allowing it to air-dry.
  • Replace the lens case according to the directions given by your ECP or the labeling that came with your case.

WARNING:

  • Contact lens cases can be a source of microbial growth.
  • DO NOT store lenses or rinse your lens case with water or any non-sterile solution. Only use fresh solution so you DO NOT contaminate your lenses or lens case. Use of non-sterile solution can lead to severe infection or vision loss (including blindness).

DISCARD DATE ON THE SOLUTION BOTTLE

Instructions for Use:

  • Discard any remaining solution after the recommended time period indicated on the bottle of the solution used for disinfecting and soaking contact lenses.

WARNING:

  • Using solution beyond the discard date could result in contamination of the solution and can lead to severe infection or vision loss (including blindness).

CHEMICAL (NOT HEAT) DISINFECTION

  • Clean the contact lenses with the cleaning solution recommended by your ECP and thoroughly rinse them with the recommended rinsing solution.
  • Some patients had trouble adapting to monovision contact lens therapy. Symptoms, such as mild blurred vision, dizziness, headaches, and a feeling of slight imbalance, may last for a brief minute or for several weeks as adaptation takes place. The longer these symptoms persist, the poorer your prognosis for successful adaptation.
  • You should avoid visually demanding situations during the initial adaptation period. It is recommended that you first wear these contact lenses in familiar situations, that are not visually demanding. For example, it might be better to be a passenger rather than a driver of an automobile during the first few days of lens wear. It is recommended that you only drive with monovision or multifocal correction if you pass your driver’s license requirements with monovision or multifocal correction.
  • Some patients will never be fully comfortable functioning under low levels of illumination, such as driving at night. If this happens, you may want to discuss with your ECP having additional contact lenses prescribed so that both eyes are corrected for distance when sharp distance binocular vision is required.
  • If you require very sharp near vision during prolonged close work, you may want to have additional contact lenses prescribed so that both eyes are corrected for near when sharp near binocular vision is required.
  • Some patients require supplemental spectacles to wear over the monovision or multifocal correction to provide the clearest vision for critical tasks. You should discuss this option with your ECP.
  • It is important that you follow your ECP’s suggestions for adaptation to monovision or multifocal contact lens therapy. You should discuss any concerns that you may have during and after the adaptation period.
  • The decision to be fitted with a monovision or multifocal correction is most appropriately left to the ECP in conjunction with you, after carefully considering and discussing your needs.

EMERGENCIES

If chemicals or hazardous substances of any kind (e.g., household products, gardening solutions, laboratory chemicals, etc.) are splashed into your eyes, you should: FLUSH EYES IMMEDIATELY WITH TAP WATER AND THEN REMOVE LENSES PROMPTLY. CONTACT YOUR ECP OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.


REPORTING OF SERIOUS INCIDENTS

Any side effects, adverse reactions, or product complaints from use of Bausch + Lomb contact lenses should be reported to the manufacturer. Country specific information can be found on www.bausch.com/contactus
Reporting of serious incidents from use of Bausch + Lomb contact lenses should be reported to the manufacturer and the relevant competent authority.


HOW BAUSCH + LOMB SOFT CONTACT LENSES ARE SUPPLIED

Each lens is provided in a foil sealed plastic container containing packaging solution. The contact lenses are supplied steam sterilised.


STORAGE CONDITIONS

Reference the temperature symbol below for the temperature storage conditions, if applicable.

The products below must be stored between 15° to 25°C (59° to 77°F):

  • PureVision® (balafilcon A) Visibility Tinted Contact Lenses
  • PureVision® Toric (balafilcon A) Visibility Tinted Contact Lenses PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lenses PureVision®2 (balafilcon A) Visibility Tinted Contact Lenses
  • PureVision®2 For Astigmatism (balafilcon A) Visibility Tinted Contact Lenses PureVision®2 For Presbyopia (balafilcon A) Visibility Tinted Contact Lenses

The products below must not be stored below 1°C (34°F):

  • Optima®38 (polymacon) Visibility Tinted Contact Lenses
  • Bausch+Lomb Lacelle Circle sterile soft colored contact Lens
  • Bausch+Lomb Lacelle Premium sterile soft colored contact Lens
  • SofLens® Series (polymacon) Contact Lenses – B4,U4 and H04 SofLens® Multi-Focal (polymacon) Visibility Tinted Contact Lenses SofLens® 38 (polymacon) Visibility Tinted Contact Lenses
  • Optima® FW (polymacon) Visibility Tinted Contact Lenses


  • After cleaning and rinsing, to disinfect, carefully follow the instructions accompanying the disinfecting solution in the care regimen recommended by your ECP.
  • When using hydrogen peroxide lens care systems, lenses must be neutralized before wearing. Follow the recommendations on the hydrogen peroxide system labeling.
  • Thoroughly rinse lenses with fresh solution recommended for rinsing before inserting and wearing or follow the Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 USA instructions on the disinfecting solution labeling.
  • DO NOT heat the disinfecting solution or lenses.
  • Leave the lenses in the closed storage case until ready to put on your eyes.

Caution: Lenses that are chemically disinfected may absorb ingredients from the disinfecting solution, which may be irritating to your eyes. A thorough rinse in fresh sterile saline solution prior to placement on your eye should reduce the potential for irritation.


LENS DEPOSITS AND USE OF ENZYMATIC CLEANING PROCEDURE

  • Enzyme cleaning may be recommended by your ECP. Enzyme cleaning removes protein deposits on the lens. These deposits cannot be removed with regular cleaners. Removing protein deposits is important for the well-being of your lenses and eyes. If these deposits are not removed, they can damage the lenses and cause irritation.
  • Enzyme cleaning does NOT replace routine cleaning and disinfecting. For enzyme cleaning, you should carefully follow the instructions in the enzymatic cleaning labeling.

CARE FOR A DRIED OUT (DEHYDRATED) LENS

If the lens is adhering to a surface, apply the rinsing solution recommended by your ECP before handling:

  • Handle the lens carefully.
  • Place the lens in its storage case and soak the lens in a recommended rinsing and storing solution for at least 1 hour until it returns to a soft state.
  • Clean the lens first, then disinfect the rehydrated lens using a recommended lens care system.
  • If after soaking the lens does not become soft or if the surface remains dry, DO NOT USE THE LENS UNTIL IT HAS BEEN EXAMINED BY YOUR ECP.

INFORMATION SPECIFIC TO MONOVISION OR MULTIFOCAL WEARER

You should be aware that as with any type of lens correction, there are advantages and disadvantages to monovision or multifocal contact lens therapy. The benefit of clear near vision in straight ahead and upward gaze that is available may be accompanied by a vision compromise that may reduce your visual acuity and depth perception for distance and near tasks.


Table: The Contact Lens Products That This IFU Applies To:

PRODUCT/MATERIAL NAME INDICATION WATER CONTENT (by weight %) PACKAGING SOLUTION REPLACEMENT PERIOD
Iconnect daily disposable (hilafilcon B) Visibility Tinted Contact Lenses spherical Borate buffered saline
SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lenses Spherical
SofLens® daily disposable Toric (hilafilcon B) Visibility Tinted Contact Lenses Astigmatism 59%
Bausch + Lomb Naturelle™ daily disposable (hilafilcon B) Cosmetically Tinted Contact Lenses Spherical Phosphate buffered saline with Poloxamine Single-use daily disposable wear, discard lens after each removal
Biotrue® ONEday (nesofilcon A) Visibility Tinted Contact Lenses Spherical
Medivision+ (nesofilcon A) Visibility Tinted Contact Lenses Spherical
Biotrue® ONEday For Astigmatism (nesofilcon A) Visibility Tinted Contact Lenses Astigmatism 78%
Biotrue® ONEday For Presbyopia (nesofilcon A) Visibility Tinted Contact Lenses Presbyopia Phosphate buffered saline with potassium chloride, poloxamine, poloxamer 181, glycerin, and erythritol
Bausch + Lomb ULTRA® ONE DAY (kalifilcon A) Contact Lenses
Lacelle Daily Colored Contact lens (Sterile Colored contact lenses) Spherical 55%
Buffered Saline Solution


HOW THE LENS WORKS (ACTIONS)

The contact lenses in Table 1 transmit between 95% to 99% visible light. When placed on the cornea in their hydrated state, all the contact lenses listed in Table 1 act as a refracting medium to focus light rays on the retina. For the Biotrue® ONEday, Medivision Daily and Bausch + Lomb ULTRA® ONE DAY contact lens products, the transmittance characteristics are less than 5% in the ultraviolet B (UVB) range of 280nm to 315nm and less than 50% in the ultraviolet A (UVA) range of 316nm to 380nm.


INDICATIONS AND INTENDED USES

Spherical: The Bausch + Lomb daily disposable soft contact lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) and reduction of spherical aberration in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

Astigmatism: The Bausch + Lomb daily disposable soft contact lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) and reduction of spherical aberration in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

Presbyopia: The Bausch + Lomb daily disposable soft contact lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D.

Refer to Table 1 for information on the replacement period for the contact lens products.

Note: Aphakic means‘lacking a focusing lens inside the eye’.


INTENDED PATIENT POPULATION

The Bausch + Lomb daily disposable soft contact lens is for use by patients prescribed the correction of refractive ametropia (including myopia, hyperopia, and astigmatism) and presbyopia by means of soft contact lenses, regardless of gender, age, or ethnicity, and who do not have contraindications for the device.


CONTRAINDICATIONS (REASONS NOT TO USE)

DO NOT USE Bausch + Lomb contact lenses when any of the following conditions exist:

  • Allergy, inflammation, infection, irritation, or redness in or around the eye
  • Dry eyes (inadequate tear fluid)
  • Any eye disease, injury (e.g., corneal abrasion), or abnormality that affects the cornea, conjunctiva, or eyelids
  • Reduced corneal sensitivity
  • Any systemic disease or poor health (e.g., colds or flu), that may affect the eye or be exaggerated by wearing contact lenses
  • Allergic reaction of ocular surfaces or surrounding tissue that may be induced or exaggerated by wearing contact lenses
  • Any active corneal infection (bacterial, fungal, or viral)
  • Patients unwilling or unable to understand or comply with any warnings, precautions, restrictions, or directions
  • Use of medications that are contraindicated for contact lens wear
  • Any previous medical intervention which may adversely affect the use of the device

WARNINGS

Problems with contact lenses could result in serious injury to your eye or in serious eye infections, including infectious keratitis. It is essential that you follow your ECP’s directions and all labeling instructions for proper use of the lenses. You should be aware of and fully discuss with your ECP the following warnings:

  • Strict compliance with your wearing restrictions, wearing schedule, replacement period, and follow-up visit schedule should be followed. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision (including blindness).
  • Daily wear lenses are not indicated for overnight wear and should not be worn while sleeping. Clinical studies have shown that the risk of serious adverse reactions is increased when daily wear lenses are worn overnight.
  • Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers.
  • Re-use of single-use daily disposable lenses could lead to lens changes that cause a higher incidence of adverse reactions.
  • If you experience eye discomfort, excessive tearing, vision changes, or redness of the eye, you should immediately remove lenses and promptly contact your ECP.
  • DO NOT use if the package is damaged or unintentionally opened.
  • DO NOT expose contact lenses to non-sterile water (e.g., tap water) while wearing them. Water can harbor microorganisms that can lead to severe infection and loss of vision (including blindness). If your lenses have been submersed in water when swimming in pools, lakes, or oceans, discard them and replace them with a new pair.
  • The Biotrue® ONEday (nesofilcon A), Medivision Daily and Bausch + Lomb ULTRA® ONE DAY (kalifilcon A) UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they DO NOT completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed.
  • Note: Long-term exposure to ultraviolet (UV) radiation is one of the risk factors associated with cataracts. Exposure is based on a number of factors such as environmental conditions (altitude, geography, cloud cover) and personal factors (extent and nature of outdoor activities). UV-blocking contact lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-blocking contact lenses reduces the risk of developing cataracts or other eye disorders. Consult your eye care practitioner for more information.
  • Note: The effectiveness of wearing UV-absorbing contact lenses in preventing or reducing the incidence of ocular disorders associated with exposure to UV light has not been established at this time.

PRECAUTIONS

You should be aware of and fully discuss with your ECP the following safety precautions:

  • Before leaving your ECP’s office, be certain that you can remove your lenses promptly or have someone else available to remove them for you.
  • Never wear your lenses beyond the period recommended by your ECP.
  • Always wash and rinse hands before handling lenses. DO NOT get cosmetics, lotions, soaps, creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses before putting on makeup. Water-based cosmetics are less likely to damage lenses than oil-based products.
  • Be certain that fingers and hands are free of foreign materials before touching your lenses, as microscopic scratches on the lenses may occur, causing distorted vision and/or injury to the eye.
  • Always handle your lenses carefully and avoid dropping them.
  • DO NOT touch the lenses with your fingernails.
  • Carefully follow the instructions in this leaflet and those recommended by your ECP for handling, insertion, removal, and wearing of contact lenses.
  • Never use tweezers or other tools to remove your lenses from the lens container unless specifically indicated for that use. Pour the lens into the hand.
  • If the lens sticks (stops moving) on the eye, follow the recommended directions in CARE FOR A STICKING (NON-MOVING) LENS. If non-movement of the lens continues, you should immediately consult your ECP.
  • Avoid, if possible, all harmful or irritating vapors and fumes when wearing lenses.
  • If your contact lenses come into contact with noxious vapor (e.g., chemical or hazardous substances), or a hazardous environment with ocular impact, they should be removed immediately.
  • DO NOT freeze.
  • DO NOT share your lenses with others.

ADVERSE REACTIONS (PROBLEMS AND WHAT TO DO)

You should be aware that the following problems may occur:

  • Eyes stinging, burning, itching (irritation), or other eye pain
  • Comfort is less than when lens was first placed on eye
  • Abnormal feeling of something in the eye (e.g., foreign body, scratched area)
  • Excessive watering (tearing) of the eyes or unusual eye secretions
  • Redness of the eyes
  • Reduced sharpness of vision (poor visual acuity)
  • Blurred vision, rainbows, or halos around objects
  • Sensitivity to light (photophobia)
  • Dry eyes

If you notice any of the above, you should IMMEDIATELY REMOVE YOUR LENSES.

  • If the discomfort or problem stops, then look closely at the lens. If the lens is in any way damaged, DO NOT put the lens back on your eye. You should discard the lens and insert a new lens. If the problem continues, you should immediately remove the lens and consult your ECP.
  • When any of the above problems occur, a serious condition such as infection, corneal ulcer, neovascularization, or iritis may be present. You should keep the lens off your eye and seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage.

TOPICS TO DISCUSS WITH YOUR EYE CARE PRACTITIONER

As with any contact lens, follow-up visits are necessary to assure the continuing health of the eyes. You should be instructed as to a recommended follow-up schedule. Patients are advised to consult with their ECP prior to:

  • Wearing lenses during sporting and water-related activities. Exposure to water while wearing contact lenses in activities such as swimming, water skiing, and hot tubs may increase the risk of ocular infection including, but not limited to, Acanthamoeba keratitis.
  • Changing the lens type or lens parameter.
  • Using any medicine in the eyes. Medications, such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, and those for motion sickness may cause dryness of the eye, increased lens awareness, or blurred vision. Should such conditions exist, proper remedial measures should be prescribed. Depending on the severity, this could include the use of rewetting drops that are indicated for use with soft contact lenses or temporary discontinuance of contact lens wear while such medication is being used.
  • Oral contraceptive and pregnant users could develop visual changes or changes in lens tolerance when using contact lenses. Patients should be cautioned by the ECP accordingly.
  • Children can successfully wear contact lenses under the oversight of an ECP and with parental supervision.
  • Wearing contact lenses when in excessively dry or dusty environments.
  • Contact your ECP if you have not worn contact lenses for a prolonged length of time.
  • Contact your ECP regarding any additional wearing restrictions that apply to you.

WHO SHOULD KNOW THAT YOU ARE WEARING CONTACT LENSES

  • Inform your doctor (health care practitioner) about being a contact lens wearer.
  • Always inform your employer of being a contact lens wearer. Some jobs may require the use of eye protection equipment or may require that you DO NOT wear contact lenses.

PERSONAL CLEANLINESS AND LENS HANDLING

PREPARING THE LENS FOR WEARING

  • Always wash your hands thoroughly with a mild soap, rinse completely, and dry with a lint-free towel before touching your lenses.
  • Avoid the use of soaps containing cold cream, lotion, or oily cosmetics before handling your lenses, since these substances may come into contact with the lenses and interfere with successful wearing.
  • Handle your lenses with your fingertips and be careful to avoid contact with fingernails. It is helpful to keep your fingernails short and smooth.

HANDLING THE LENSES

  • Always insert and remove the same lens first to avoid mix-ups.
  • Position the lens on your index finger and examine the lens to be sure that it is moist, clean, clear, and free of any nicks or tears. Make sure the lens is the right way out.
  • Should you accidentally place an inside-out lens on your eye, one of the following signs should signal you to remove and replace it correctly:
    • Less than usual comfort
    • The lens may fold on the eye
    • Excessive lens movement on blink o Blurred vision
  • If the lens folds and sticks together, place the lens in the palm of your hand and wet thoroughly with the rewetting solution recommended by your ECP. Then GENTLY rub the lens between your index finger and palm in a back and forth motion.
  • If the lens flattens or drapes across your finger, the lens or your finger may be too wet. To correct this, dry your finger by transferring the lens several times from one index finger to the other, drying the opposite finger each time.

PLACING THE LENS ON THE EYE:

The One Hand Placement Technique

Place the lens on your index finger. With your head up, looking straight ahead, pull down your lower eyelid with the middle finger of your placement hand. Look up steadily at a point above you. Then place the lens on the lower white part of your eye. Remove your index finger and slowly release the lower eyelid. Look down to position the lens properly. Close your eyes for a moment and the lens should center itself on your eye.

The Two Hand Placement Technique

With the lens on your index finger, use the middle finger of the other hand to pull the upper eyelid against the brow. Use the middle finger of your placement hand to pull down the lower eyelid and then place the lens centrally on your eye. While holding this position, look downward to position the lens properly. Slowly release your eyelids.

  • Some patients had trouble adapting to monovision contact lens therapy. Symptoms, such as mild blurred vision, dizziness, headaches, and a feeling of slight imbalance, may last for a brief minute or for several weeks as adaptation takes place. The longer these symptoms persist, the poorer your prognosis for successful adaptation.
  • You should avoid visually demanding situations during the initial adaptation period. It is recommended that you first wear these contact lenses in familiar situations, that are not visually demanding. For example, it might be better to be a passenger rather than a driver of an automobile during the first few days of lens wear. It is recommended that you only drive with monovision or multifocal correction if you pass your driver’s license requirements with monovision or multifocal correction.
  • Some patients will never be fully comfortable functioning under low levels of illumination, such as driving at night. If this happens, you may want to discuss with your ECP having additional contact lenses prescribed so that both eyes are corrected for distance when sharp distance binocular vision is required.
  • If you require very sharp near vision during prolonged close work, you may want to have additional contact lenses prescribed so that both eyes are corrected for near when sharp near binocular vision is required.
  • Some patients require supplemental spectacles to wear over the monovision or multifocal correction to provide the clearest vision for critical tasks. You should discuss this option with your ECP.
  • It is important that you follow your ECP’s suggestions for adaptation to monovision or multifocal contact lens therapy. You should discuss any concerns that you may have during and after the adaptation period.
  • The decision to be fitted with a monovision or multifocal correction is most appropriately left to the ECP in conjunction with you, after carefully considering and discussing your needs.

EMERGENCIES

If chemicals or hazardous substances of any kind (e.g., household products, gardening solutions, laboratory chemicals, etc.) are splashed into your eyes, you should: FLUSH EYES IMMEDIATELY WITH TAP WATER AND THEN REMOVE LENSES PROMPTLY. CONTACT YOUR ECP OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.


REPORTING OF SERIOUS INCIDENTS

Any side effects, adverse reactions, or product complaints from use of Bausch + Lomb contact lenses should be reported to the manufacturer. Country specific information can be found on www.bausch.com/contactus
Reporting of serious incidents from use of Bausch + Lomb contact lenses should be reported to the manufacturer and the relevant competent authority.


HOW BAUSCH + LOMB SOFT CONTACT LENSES ARE SUPPLIED

Each lens is provided in a foil sealed plastic container containing packaging solution. The contact lenses are supplied steam sterilised.


STORAGE CONDITIONS

Reference the temperature symbol below for the temperature storage conditions, if applicable. The products below must not be stored below 1°C (34°F):

  • Lacelle Daily colored contact Lens
  • SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lenses SofLens® daily disposable Toric (hilafilcon B) Visibility Tinted Contact Lenses
  • Bausch + Lomb Naturelle™ daily disposable (hilafilcon B) Cosmetically Tinted Contact Lenses
  • Biotrue® ONEday (nesofilcon A) Visibility Tinted Contact Lenses
  • Biotrue® ONEday For Astigmatism (nesofilcon A) Visibility Tinted Contact Lenses
  • Biotrue® ONEday For Presbyopia (nesofilcon A) Visibility Tinted Contact Lenses

If the lens feels uncomfortable, then:

Look in a mirror and gently place a finger on the edge of the contact lens and slowly slide the lens away from your nose while looking in the opposite direction. Then by blinking, the lens will recenter itself. If the lens still feels uncomfortable, follow the steps described in ADVERSE REACTIONS (PROBLEMS AND WHAT TO DO).

Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 USA


CENTERING THE LENS

If after placement of the lens your vision is blurred, check for the following:

  • The lens is not centered on the eye. To center a lens, follow one of the procedures below:
    • Hold the upper and lower eyelids open with your fingers. Then, while looking in a mirror, gently place a finger on the contact lens and slide the lens towards the center of the eye.
    • OR

    • Hold the upper and lower eyelids open with your fingers. Then, while looking in a mirror, move your eye towards the lens to place it on the center of the eye.
  • If the lens is centered, remove the lens and check for the following:
    • Cosmetics or oils on the lens. Discard the lens and use another lens. o The lens is on the wrong eye.
    • The lens is inside-out (it would not be as comfortable as normal).

If you find that your vision is still blurred after checking the above, remove both lenses and consult your ECP.


REMOVING THE LENS

  • Always remove the same lens first.
  • Wash, rinse, and dry your hands thoroughly.
  • Always be sure that the lens is in the correct position on your eye before you try to remove it (a simple check of your vision, closing one eye at a time, will tell you if the lens is in the correct position). Look up and slowly pull down your lower eyelid with the middle finger of your removal hand and place your index finger on the lower edge of the lens. Squeeze the lens lightly between the thumb and index finger and remove it. Avoid sticking the edges of the lens together.
  • Remove the other lens by following the same procedure.
  • Use rewetting drops recommended by your ECP if lens is difficult to remove.
  • Note: If this method of removing your lens is difficult for you, your ECP will provide you with an alternative method.


CARE FOR A STICKING (NON-MOVING) LENS

If a lens sticks (stops moving), put a few drops of the rewetting solution recommended by your ECP into your eye. DO NOT use plain water or anything other than the recommended solutions. DO NOT attempt to remove a lens that is sticking, which could damage your eye. If the lens does not begin to move when you blink after several applications of the solution, immediately contact your ECP. DO NOT attempt to remove the lens except on the advice of your ECP.


INFORMATION SPECIFIC TO MONOVISION OR MULTIFOCAL WEARER

You should be aware that as with any type of lens correction, there are advantages and disadvantages to monovision or multifocal contact lens therapy. The benefit of clear near vision in straight ahead and upward gaze that is available may be accompanied by a vision compromise that may reduce your visual acuity and depth perception for distance and near tasks.

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