1-Day Acuvue TruEye Instructions and Precautions

Introduction

Congratulations on choosing 1-Day Acuvue TruEye (narafilcon A) Contact Lenses with UV Blocker for Daily Wear Frequent Replacement. In the 1-Day Acuvue TruEye Contact Lenses, a UV absorbing monomer is used to block UV radiation. When your prescribed replacement period is over, you simply throw the used lens away and replace it with a new sterile one. By replacing your 1-Day Acuvue TruEye (narafilcon A) Contact Lens on a regular basis, lens deposits, which can affect vision and cause irritation and discomfort to the eye, have little chance to build up over time as with conventional lens wear. When you discard the lens, you dispose of potential deposit build-up problems.

1-Day Acuvue TruEye Contact Lenses are soft spherical lenses. They are made from a "water-loving" (hydrophilic) material that has the ability to absorb water, making the lens soft and flexible. They differ from other lenses available because of the way they are manufactured. Simply put, the multi-patented manufacturing process which took years to perfect, makes 1-Day Acuvue TruEye (narafilcon A) Contact Lens frequent replacement possible. Since the lenses are produced identically one after another, you will experience the same excellent comfort and vision, lens after lens after lens.

The information and instructions contained in this booklet apply only to the 1-Day Acuvue TruEye (narafilcon A) Contact Lens. 1-Day Acuvue TruEye (narafilcon A) Contact Lenses are intended to be used for daily and extended wear within the VISTAKON(r) planned lens replacement system. For your eye health, it is important that the 1-Day Acuvue TruEye (narafilcon A) Contact Lenses be worn only as prescribed by your Eye Care Professional. Your Eye Care Professional should be kept fully aware of your medical history.

Your Eye Care Professional will tailor a total program of care based on your specific needs. He or she will review with you all instructions for lens handling and care, including how to safely and easily open the packaging. You will also be instructed on how to properly apply and remove lenses. This booklet will reinforce those instructions. After the accumulated wearing period prescribed by your Eye Care Professional, your 1-Day Acuvue TruEye (narafilcon A) Contact Lenses should be discarded and replaced with a new sterile pair. If you have any questions, always ask your Eye Care Professional.

 

Wearing Restrictions and Indications

1-Day Acuvue TruEye (narafilcon A) Contact Lenses (spherical) are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism and/or enhance or alter the apparent color of the eye for lenses with cosmetic tint.

1-Day Acuvue TruEye (narafilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The 1-Day Acuvue TruEye (narafilcon A) Contact Lenses may be prescribed for daily wear. They should be removed from your eyes and discarded as prescribed by your Eye Care Professional.

Warning: 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 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). Your UV blocking Acuvue TruEye 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 Professional for more information.

 

Contraindications (reasons not to use)

DO NOT USE the 1-Day Acuvue TruEye (narafilcon A) Contact Lens when any of the following conditions exist:

  • Acute or subacute inflammation or infection of the anterior chamber of the eye
  • Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids
  • Severe insufficiency of lacrimal secretion (dry eyes)
  • Corneal hypoesthesia (reduced corneal sensitivity), if not-aphakic
  • Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses
  • Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
  • Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care for the 1-Day Acuvue TruEye (narafilcon A) Contact Lens
  • Any active corneal infection (bacterial, fungal, protozoal, or viral)
  • If eyes become red or irritated

 

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.
  • 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 TruEye (narafilcon 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 Acuvue TruEye lenses stick (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 1-Day Acuvue TruEye 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.

 

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