Overview

Avaira contact lenses are are made from a material containing 46% water and 54% enfilcon A, a silicone containing hydrogel. The lenses have a tint (phthalocyanine blue) which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer which is used to block UV radiation.

Contact lens parameters:

  • Diameter: 13.5 mm to 15.0 mm
  • Base Curve: 8.2 mm to 9.2 mm
  • Center Thickness: 0.08 mm to 0.60 mm (varies with power)
  • Powers: -20.00 D to +20.00D

The physical/optical properties of the Avaira lens are:

  • Refractive Index: 1.40
  • Light Transmittance: >97%
  • Surface Character: Hydrophilic
  • Water Content: 46%
  • Specific Gravity: 1.06
  • Contact angle 37 deg
  • Oxygen Permeability: 100 x 10-11 (cm2/sec)(ml 02/ml x mmHg) 35°C(Polarographic method)

How supplied

Each lens is supplied sterile in a blister pack containing buffered isotonic saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens.

Do not use if the blister pack is broken or the seal has been damaged!

Wearing Schedule

The wearing and replacement schedules should be determined by your eye care practitioner. Do not over-wear the lenses. Your eye care practitioner should emphasize the importance of adhering to the initial maximum wearing schedule. Regular checkups, as determined by the eye care practitioner are also extremely important.

CooperVision recommends that all Avaira contact lenses be discarded and replaced with a new lens on a frequent replacement basis. Your eye care practitioner is encouraged to determine an appropriate lens replacement schedule based upon the response of the patient.

For DAILY WEAR (less than 24 hours, while awake) the maximum suggested wearing time is:

  • On Day 1:  6 hours

  • On Day 2:  8 hours

  • On Day 3:  10 hours

  • On Day 4:  12 hours

  • On Day 5:  14 hours

  • On Day 6:  All waking hours

Actions

When placed on the cornea in its hydrated state, the Avaira (enfilcon A) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina. The toric lens provides a more even surface over the highly uneven astigmatic cornea and thus helps to focus light rays on the retina. The thinnest Avaira (enfilcon A) Soft (Hydrophilic) Contact Lens (-2.00 to -10.00 D) blocks 75% of UVA radiation and 99% UVB radiation average across the spectrum. The radiation blockage of the AVAIRA lens will increase for thicker lenses.

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 the surrounding area. You should continue to use absorbing eyewear as directed. Long term exposure to the 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 the outdoor activities). UV- absorbing contact lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-absorbing contact lenses reduces the risk of developing cataracts or other eye disorders. Consult your eye care practitioner for more information.

Indications for Use

Spherical and Aspherical Avaira (enfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Avaira contact lenses are indicated for daily wear. As prescribed for frequent replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Contraindications

Do not use Avaira contact lenses when any of the following conditions exist:

  • Acute and 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 any AVAIRA lens.

  • Any active corneal infection (bacterial, fungal, or viral).

  • If eyes become red or irritated.

  • The patient is unable to follow lens care regimen or unable to obtain assistance to do so.

Warnings

CooperVision advises you (as a patient) of the following warnings pertaining to contact lens wear:

  • Problems with contact lenses and lens care products could result in serious injury to the eye. It is essential that you follow your eye care practitioner’s directions and all labeling instructions for proper use of lenses and lens care products.  You should fill your lens case with fresh solution every time they store their lenses, and never re-use solution. Additionally, you should discard the solution immediately after your lenses have been removed from the lens case, rinse the case with fresh solution, and to allow the case to air dry. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision.

  • Problems with contact lenses and lens care products could result in serious injury to the eye. It is essential to follow your eye care practitioner’s directions and all labeling instructions for proper use of lenses and lens care products, including the lens case. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision.

  • All contact lens wearers must see their eye care practitioner as directed.

  • Daily wear lenses are not indicated for overnight wear, and you should be instructed not to wear lenses while sleeping. Clinical studies have shown that the risk of serious adverse reactions is increased when these lenses are worn overnight.

  • The risk of ulcerative keratitis has been shown to be greater among users of extended wear lenses than among users of daily wear lenses.

  • Studies have been shown that contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers.

  • If you experience eye discomfort, excessive tearing, vision changes, or redness of the eye, you should immediately remove the lenses and promptly contact your eye care practitioner.

Precautions

  • Do not use saliva or anything other than the recommended solutions for lubricating or wetting lenses.

  • If the lens sticks (stops moving) on the eye, follow the recommended directions on 'Care for a Sticking Lens'. The lens should move freely on the eye for the continued health of the eye. If non-movement of the lens continues, you should immediately consult your eye care practitioner.

  • 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.

  • Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions, soaps, creams, deodorant, 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.

  • Do not touch the contact lenses with the finger or hands if the hands are not free of foreign materials, as lens damage may occur.

  • Carefully follow the handling, insertion, removal, cleaning, and wearing instructions in the Patient Instructions for AVAIRA contact lenses and those prescribed by the eye care practitioner.

  • Never wear lenses beyond the period recommended by the eye care practitioner.

  • If aerosol products such as hairspray are used while wearing lenses, exercise caution and keep eyes closed until the spray has settled.

  • Always handle lenses gently and avoid dropping them.

  • Avoid all harmful or irritating vapors and fumes while wearing lenses.

  • Ask your eye care practitioner about wearing Avaira contact lenses during sporting activities.

  • Inform your doctor (health care practitioner) about being a contact lens wearer.

  • Never use tweezers or other tools to remove lenses from the lens container unless specifically indicated for that use. Pour the lens into your hand.

  • Do not touch the lens with fingernails.

  • Always discard disposable lenses and lenses worn on a frequent replacement schedule after the recommended wearing schedule prescribed by the eye care practitioner.

  • Always contact your eye care practitioner before using any medicine in the eyes.

  • Always inform your employer of being a contact lens wearer. Some jobs may require use of eye protection equipment or may require that the patient not wear contact lenses.

  • As with any contact lens, follow-up visits are necessary to assure the continuing health of the patient’s eyes. You should be instructed as to a recommended follow-up schedule.

Adverse Reations

As a patient please be informed that the following problems may occur:

  • Eyes stinging, burning, or itching (irritation), or other eye pain.

  • Comfort is less than when the lens was first placed on the eye.

  • Feeling that something is in the eye such as a foreign body or a scratched area.

  • Excessive watering (tearing) of the eyes.

  • 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:

  • Immediately remove the lenses.

  • If the discomfort or the problem stops, then look closely at the lens. If the Avaira contact lens is in some way damaged, do not put the lens back on the eye. Place the lens in the storage case and contact the eye care practitioner. If the lens has dirt, an eyelash, or other foreign body on it, or the problem stops and the lens appears undamaged, you should thoroughly clean, rinse, and disinfect both lenses; then reinsert them. After reinsertion, if the problem continues, immediately remove the lenses and consult your eye care practitioner.

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