This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: BIOFINITY® (comfilcon A) Soft Contact Lens for Extended Wear
PMA Applicant: CooperVision, Inc.
Address: 6140 Stoneridge Mall Road, Suite 500, Pleasanton, CA 94588
Approval Date: November 19, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080011a.pdf
What is it? BIOFINITY® is an extended wear soft contact lens that may be worn continuously for up to 6 nights and 7 days. The lens material is approximately 48% water and 52% comfilcon A (a silicone-containing hydrogel).
How does it work? When placed on the eye, the lens focuses light onto the retina (the light-sensitive area in the back of the eye). The lens material permits a high level of oxygen to reach the eye, which helps to maintain the eye's natural function during wear.
When is it used? The lens may be prescribed for extended wear use for up to 6 nights and 7 days of continuous wear. It is recommended that the contact lens wearer be first evaluated on a daily wear schedule prior to overnight wear. The lenses may be prescribed for either one week disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement. When prescribed for frequent replacement, the lenses must be cleaned and disinfected using a chemical disinfection system only.
What will it accomplish? The lens corrects conditions in which the eye does not focus light properly (refractive error), such as near-sightedness (myopia) and far-sightedness (hyperopia). Approximately 95% of patients in a clinical study achieved at least 20/25 vision with the BIOFINITY® lenses.
When should it not be used? The lens should not be used 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 BIOFINITY® 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.
Additional information: The Summary of Safety and Effectiveness and Labeling is available online.