Warnings

Problems with contact lenses or lens care products could result in serious injury to the eye. Proper use and care of contact lenses and lens care products, including lens cases, are essential for the safe use of these products.

The following warnings pertain to contact lens wear: Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision.

The results of a study indicate the following:

• The overall annual incidence of ulcerative keratitis in daily wear contact lens users is estimated to be about 4.1 per 10,000 persons and about 20.9 per 10,000 persons in extended wear contact lens users.
• The risk of ulcerative keratitis is 4 to 5 times greater for extended wear contact lens users than for daily wear users. When daily wear users who wear their lenses overnight and extended wear users who wear their lenses on a daily basis are excluded from the comparison, the risk among extended wear users is 10 to 15 times greater than among daily wear users.
• When daily wear users wear their lenses overnight (outside the approved indication), the risk of ulcerative keratitis is 9 times greater than among those who do not wear them overnight.
• The overall risk of ulcerative keratitis may be reduced by carefully following directions for lens care, including cleaning the lens case.
• The risk of ulcerative keratitis among contact lens users who smoke is estimated to be 3 to 8 times greater than among non-smokers.

If you experience eye discomfort, excessive tearing, vision changes, redness of the eye or other problems, you should immediately remove your lenses and promptly contact your Eye Care Professional.
It is recommended that you see your Eye Care Professional routinely, as directed.

Precautions

• DO NOT use if the sterile blister package is opened or damaged.
• Patients who wear contact lenses to correct presbyopia using Monovision may not achieve the best corrected visual acuity for either far or near vision. Visual requirements vary with the individual and should be considered when selecting the most appropriate type of lens.
• When wearing lenses that alter your eye color, you may notice temporary differences in your vision due to the presence of the color in the lens, especially in conditions of low light. If these differences in vision persist when wearing ACUVUE(r) 2 COLOURS(tm) Brand, it is important that you consult your Eye Care Professional.
• Before leaving the Eye Care Professional's office, you should be able to promptly remove lenses or you should have someone else available who can remove the lenses for you.
• You should remove your lenses immediately if your eyes become red or irritated.
• Different solutions cannot always be used together, and not all solutions are safe for use with all lenses. Use only recommended solutions.
• Never use solutions recommended for conventional hard contact lenses only.
  • Chemical disinfection solutions should not be used with heat unless specifically indicated on product labeling for use in both heat and chemical disinfection.
  • Always use fresh, unexpired lens care solutions and lenses.
  • Always follow directions in the Package Insert for the use of contact lens solutions.
  • Use only a chemical (not heat) lens care system. Use of heat (thermal) care systems can damage the 1-Day Acuvue Define (etafilcon A) Contact Lens.
  • Sterile unpreserved solutions, when used, should be discarded after the time specified in the labeling directions.
  • Do not use saliva or anything other than the recommended solutions for lubricating or wetting lenses.
  • Always keep your lenses completely immersed in the recommended storage solution when the lenses are not being worn (stored). Prolonged periods of drying will reduce the ability of the lens surface to return to a wettable state. Follow the lens care directions for "Care for a Dried Out (Dehydrated) Lens" if lens surface does become dried out.
• If the lens sticks (stops moving) on your eye, follow the recommended directions in "Care for a Sticking Lens". The lens should move freely on your eye for the continued health of your eye. If non-movement of your lens continues, you should immediately consult your Eye Care Professional.
• Always wash and rinse your hands before handling lenses. Do not get cosmetics, lotions, soaps, creams, deodorants, or sprays in your eyes or on your lenses. It is best to put on your lenses before putting on makeup. Water-based cosmetics are less likely to damage lenses than oil-based products.
• Do not touch your contact lenses with your fingers or hands if they are not free of foreign material, as microscopic scratches of the lenses may occur, causing distorted vision and/or injury to your eye.
• Carefully follow the handling, application, removal, cleaning, disinfecting, storing and wearing instructions in this booklet and those prescribed by your Eye Care Professional.
• Never wear your lenses beyond the period recommended by your Eye Care Professional.
• Never allow anyone else to wear your lenses. They have been prescribed to fit your eyes and to correct your vision to the degree necessary. Sharing lenses greatly increases the chance of eye infections.
• If aerosol products, such as hair spray, are used while wearing lenses, exercise caution and keep your eyes closed until the spray has settled.
• Always handle lenses carefully and avoid dropping them.
• Avoid all harmful or irritating vapors and fumes while wearing lenses.
• Ask your Eye Care Professional about wearing contact lenses during sporting activities, especially swimming and other water sports. Exposing contact lenses to water during swimming or while in a hot tub may increase the risk of eye infection from microorganisms.
• Inform your doctor (Health Care Practitioner) about being a contact lens wearer.
• Never use tweezers or other tools to remove your lenses from the lens container unless specifically indicated for that use. Slide the lens up the side of the bowl.
• Do not touch the lens with your fingernails.
• Always discard lenses worn on a frequent replacement schedule after the recommended wearing schedule prescribed by your Eye Care Professional.
• Always contact your Eye Care Professional before using any medicine in your eyes.
• Always inform your employer of being a contact lens wearer. Some jobs may require use of eye protection equipment or may require that you not wear contact lenses.
• Certain medications, such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers and those for motion sickness, may cause dryness to 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 lubricating drops that are indicated for use with soft contact lenses or the 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.
• As with any contact lens, follow-up visits are necessary to assure the continuing health of your eyes.

Adverse Reactions (Problems and What to do)

The following problems may occur when wearing contact lenses:

• Your eyes may burn, sting and/or itch.
• There may be less comfort than when the lens was first placed on your eye.
• There may be a feeling of something in your eye (foreign body, scratched area).
• There may be the potential for some temporary impairment due to peripheral infiltrates, peripheral corneal ulcers or corneal erosion. There may be the potential for other physiological observations, such as local or generalized edema, corneal neovascularization, corneal staining, injection, tarsal abnormalities, iritis and conjunctivitis, some of which are clinically acceptable in low amounts.
• There may be excessive watering, unusual eye secretions or redness of your eye.
• Poor visual acuity, blurred vision, rainbows or halos around objects, photophobia or dry eyes may also occur if your lenses are worn continuously or for too long a time.

You should conduct a simple 3-part self examination at least once a day. Ask yourself:

• How do the lenses feel on my eyes?
• How do my eyes look?
• Do I continue to see well?

If you report any problems, you should IMMEDIATELY REMOVE YOUR LENS.

If the discomfort or problem stops, you should look closely at the lens.

If the lens is in any way damaged, you SHOULD NOT put the lens back on your eye. You should discard the lens and apply a new fresh lens on your eye.

If your lens has dirt, an eyelash, or foreign body on it, or the problem stops and the lens appears undamaged, you should dispose of the lens and apply a new fresh lens.

If the problem continues, you SHOULD NOT put the lens back on your eye but IMMEDIATELY CONSULT YOUR EYE CARE PROFESSIONAL.

When any of the above symptoms occur, a serious condition such as infection, corneal ulcer, neovascularization or iritis may be present. Seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage.