Decorative Contact Lenses, Wearer Beware
The Food and Drug Administration (FDA) is
warning consumers about serious risks of permanent eye injury, potentially
leading to blindness, presented by non-corrective, decorative contact lenses
distributed without a prescription and without proper fitting by an eye care
professional. FDA has learned that these products are being marketed and
distributed directly to consumers through flea markets, convenience stores, and
beach shops. Marketing of decorative lenses may increase during the upcoming
Halloween season.
Decorative contact lenses present significant risks of blindness and other
eye injury if they are distributed without a prescription or without proper
fitting by a qualified eye care professional. FDA has received reports of
corneal ulcer associated with wear of decorative contact lenses in excess of the
recommended period. Corneal ulcer can progress rapidly, leading 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.
Other risks associated with use of decorative contact lenses include
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.
"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 FDA Deputy Commissioner Dr.
Lester M. Crawford. "FDA will aggressively use the full range of its statutory
authorities to prevent the distribution of these potentially dangerous products
directly to consumers."
FDA is issuing an import alert instructing FDA and Customs officials to
detain automatically all decorative contact lenses presented at United States
ports of entry. FDA will seize decorative contact lenses currently on the market
in violation of federal law. FDA is also communicating with the public and with
the eye care professional community concerning the dangers of using decorative
contact lenses.
Consumers are urged to discontinue immediately use of 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.
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.
This information has been provided with the kind permission of the Food and
Drug Administration, press release# P02-43, October 21, 2002.
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Last Editorial Review: 10/28/2002