Oct. 29, 2004 This Halloween season, the Food and Drug Administration (FDA) is again warning consumers about the serious risks of using decorative contact lenses distributed without appropriate involvement by an eye care professional. These decorative lenses can cause permanent eye injury and may potentially lead to blindness. FDA has received reports of decorative contact lenses being marketed and distributed 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 upcoming Halloween season.
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 (an infection of the eye); corneal edema (swelling); allergic reaction and corneal abrasion due to poor lens fit. Other problems may include reduction in visual acuity (sight), contrast sensitivity and other visual functions, resulting in interference with driving and other activities.
"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 the appropriate involvement of a qualified eye care professional," said Dr. Lester M. Crawford, Acting FDA Commissioner. "FDA will aggressively use the full range of its statutory authorities to prevent the improper distribution of these potentially dangerous products."
The FDA has issued an import alert for decorative contact lenses presented at United States ports of entry that are intended for distribution without the appropriate involvement of an eye care professional. The Agency has examined and detained numerous shipments of these lenses. Because there has been no demonstration to FDA's satisfaction that any of these detained products, when distributed without eye care professional involvement, comply with federal safety standards, these products have not been permitted to enter United States commerce.
Domestically, FDA has issued several warning letters, including a warning letter sent to Beauty Supply d/b/a Beauty World, of District Heights, MD. FDA informed that company that the Agency considers the lenses to be adulterated because they are being distributed to consumers without appropriate eye care professional involvement, and also mislabeled because the lenses' labeling fails to warn consumers about the potential injuries that might result from wearing the lenses.
FDA urges consumers not to use decorative contact lenses unless they have seen an eye care professional, and have obtained proper lens fitting and instructions for using the lenses. FDA requests that consumers report any problems with decorative contact lenses to the FDA district office consumer complaint coordinator in their 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 . You 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.
More information on decorative contact lenses can be found on the FDA's web site http://www.fda.gov/cdrh/safety/declensenorx.html
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