INSTRUCTIONS FOR USE FOR BAUSCH + LOMB SOFT 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.