FDA Warns Consumers Not to Use Decorative Contact Lenses Without Proper Professional Involvement

WASHINGTON, D.C. -- With the Halloween season approaching, the Food and Drug Administration (FDA) is warning consumers about serious risks of using decorative contact lenses distributed without appropriate involvement from an eye care professional. These decorative lenses can cause permanent eye injury and may potentially lead to blindness.

The FDA has received reports of decorative contact lenses being marketed and distributed directly to consumers through sources such as flea markets, convenience stores, beach shops and the Internet. The FDA has received reports of corneal ulcers associated with the wearing of decorative contact lenses in excess of the recommended period. Corneal ulcers can progress rapidly, and, if left untreated, could lead to infection of the eye. Uncontrolled infection can lead to corneal scarring and vision impairment. In the most severe cases, this condition can result in blindness and eye loss.

Other risks associated with the use of decorative contact lenses include conjunctivitis; corneal edema; allergic reaction and corneal abrasion due to poor lens fit. Other problems may include reduction in visual acuity, contrast sensitivity and other visual functions, resulting in interference with driving and other activities.

"Although decorative contact lenses may seem festive during this time of year, consumers should understand that these lenses can seriously harm the eye if they are used without appropriate supervision by an eye care professional," said FDA Commissioner Mark B. McClellan. "FDA is committed to protecting the public health by taking strong action against those who would put consumers at risk by improperly distributing these products."

The FDA has issued an import alert for decorative contact lenses presented for importation into the United States that are intended for distribution without the appropriate involvement of an eye care professional.

The FDA has examined numerous entries of decorative contact lenses presented for importation. Currently, there has been no demonstration to FDA's satisfaction that these products, when distributed without eye care professional involvement, comply with federal safety standards. Consequently, these products have not been permitted to enter United States commerce.

Domestically, FDA has inspected several firms distributing decorative contact lenses, and additional inspections are planned. FDA has recently issued a warning letter to BWild Incorporated, warning the firm that it is selling decorative contact lenses without proper labeling about the risks and proper instructions for safe use. FDA will take action with respect to other firms distributing these products as appropriate. Recently, the FDA also sent letters to Yahoo! and the online auction site eBay, alerting them to the risks of decorative contact lenses distributed without appropriate eye care professional involvement and requesting their assistance in preventing improper online sales.

FDA urges consumers not to use decorative contact lenses unless they have seen an eye care professional and have obtained proper fitting and instructions for using the product.

More information on decorative contact lenses can be found on the FDA's Web site http://www.fda.gov/cdrh/safety/declensenorx.html