FDA NEWS RELEASE

FDA Reminds Consumers of Serious Risks of Using Decorative Contact Lenses without Consulting Eye Care Professional
Risk of Permanent Eye Injury that May Lead to Blindness

This Halloween season, the U.S. Food and Drug Administration (FDA) is again warning consumers about the serious risks of using decorative contact lenses without the appropriate involvement of an eye care professional. These contact lenses, sometimes called Plano or non-corrective lenses, do not correct vision and are intended solely to change the appearance of the eye, but carry serious risks, including permanent eye injury that may lead to blindness.

Consumers should only use decorative contact lenses if they have seen an eye care professional and have obtained proper lens fitting and instructions for use.

Decorative contact lenses also carry the same risks as corrective contact lenses, including conjunctivitis (pink eye); corneal (the eye's outermost layer) ulcers; corneal abrasion; and vision impairment or blindness. Further, sharing of contact lenses prescribed for one person can also lead to infections, abrasions, allergic reaction or blindness.

FDA has received reports of corneal ulcers associated with the wearing of decorative contact lenses, especially when worn overnight. Corneal ulcers, an infection of the eye, can progress rapidly if left untreated. Uncontrolled infection can lead to corneal scarring and vision impairment. In the most severe cases, this condition can result in blindness and eye loss.

FDA has received reports of decorative contact lenses being marketed and distributed without a prescription directly to consumers through sources such as beauty salons, flea markets, convenience stores, beach shops and the Internet. Marketing of decorative lenses may increase during the Halloween season.

On Nov. 9, 2005, the Food, Drug and Cosmetic Act was amended to classify all contact lenses—including decorative ones—as medical devices under FDA's regulatory authority. Contact lenses distributed without appropriate involvement by eye care professionals are now considered misbranded devices under the law. FDA will aggressively use the full range of its statutory authorities to prevent the improper distribution of these potentially dangerous products.

Consumers should report any problems with decorative contact lenses to their local FDA office. For a listing of FDA offices, visit www.fda.gov/opacom/backgrounders/complain.html. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20852-9787, or through the MedWatch Web site at www.fda.gov/medwatch.

For more information, visit www.fda.gov/cdrh/contactlenses/types.html#plano.

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