Dateline: 10/22/02

The Food and Drug Administration (FDA) on October 22, 2002 warned consumers that extended use of non-corrective, decorative contact lenses could result in serious eye injury, potentially leading to blindness.

According to the FDA, extended use of decorative contact lenses, sold to consumers without a prescription and without proper fitting by an eye care professional, could lead to permanent eye damage. 

FDA advises that the decorative contact lenses are being marketed and distributed directly to consumers through flea markets, convenience stores, beach shops and the Internet. Along with changing eye color, the latest variety of decorative contacts are used for producing special effects, such as mimicking the eyes of cats, snakes and wolves, and displaying written messages. Marketing of decorative lenses is particularly heavy during the Halloween party season, warns the FDA.

Health Risks of Decorative Contact Lens Use
Cases of corneal ulcer associated with wear of decorative contact lenses in excess of the recommended period have been reported to the FDA. Corneal ulcer can progress rapidly and lead to internal ocular infection if left untreated. Uncontrolled infection can lead to corneal scarring and vision impairment. In extreme cases, this condition can result in blindness and eye loss, according to the FDA.

FDA also warns of other eye risks associated with use of decorative contact lenses, including:

• conjunctivitis (an infection of the eye);
• corneal edema (swelling); 
• allergic reaction; 
• corneal abrasion from poor lens fit; and
• reduction in visual acuity, contrast sensitivity, and other visual functions, resulting in interference with driving and other activities.

According to FDA Deputy Commissioner Dr. Lester M. Crawford, while the FDA has approved the prescription-only sale of some contact lenses for cosmetic use, such as colored lenses. However, noted Dr. Crawford, FDA's approval guarantees these lenses were made under sterile conditions, and requires that consumers be told how to insert and care for the lenses in a way that minimizes chances of such side effects as infections or abrasions.

"Consumers should understand that decorative contact lenses, like contact lenses intended for correcting vision, present serious risks to eye health if they are distributed without a valid prescription and proper fitting by a qualified eye care professional," said Dr. Crawford. "FDA will aggressively use the full range of its statutory authorities to prevent the distribution of these potentially dangerous products directly to consumers."

In association with its warning to consumers, the FDA issued and alter to U.S. Customs officials to detain automatically all decorative contact lenses presented at United States ports of entry. In addition, the FDA announced it would attempt to seize decorative contact lenses not granted FDA approval and marketed in violation of federal law. FDA is also communicating with the eye care professional community concerning the dangers of using decorative contact lenses.

Consumers should also read Buying Contact Lenses on the Internet, by Phone, or by Mail, a complete question and answer publication of the FDA, available online at: http://www.fda.gov/cdrh/consumer/buycontactqa.html

Reporting Complaints or Problems
FDA urges consumers to immediately stop using decorative contact lenses obtained without proper fitting and a prescription and to notify FDA of any complaints or problems associated with these products. 

FDA requests that consumer reports be submitted to the FDA district office consumer complaint coordinator for your geographic area. Telephone and TTY contact information for FDA's consumer complaint coordinators is available via FDA's web site at http://www.fda.gov/opacom/backgrounders/complain.html.

Consumers may also report problems or complaints to MedWatch, the FDA’s voluntary reporting program, by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane (HF-2), Rockville, MD 20850.