Dear Doctor Column, October 27, 2003
FDA Warns of Decorative Contact Lens Dangers
Question:
Are contact lenses you purchase at a costume store safe to wear?
Answer:
This Halloween, the Food and Drug Administration (FDA) is once again warning consumers about the risks of blindness and other serious, and potentially permanent, eye injuries from the use of decorative contact lenses distributed without a prescription and without proper fitting by an eye-care professional.
According to the FDA, these products are marketed and distributed directly to consumers through flea markets, convenience stores, beach shops, and the Internet, to name a few places, particularly around Halloween. Along with changing eye color, the variety of decorative contacts are used for producing special effects, such as mimicking the eyes of cats, snakes, and wolves, and displaying written messages.
The FDA has received reports of ulcers on the cornea, the clear covering of the eye, associated with the wear of decorative contact lenses in excess of the recommended period. A corneal ulcer can progress rapidly, leading to internal ocular infection if left untreated. Uncontrolled infection can lead to permanent corneal scarring and vision impairment. In extreme cases, this condition can result in blindness and eye loss, advises the FDA.
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.
Although the FDA has approved the prescription-only sale of some contact lenses for cosmetic use, such as colored lenses, the 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 to minimize chances of 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 FDA Deputy Commissioner Dr. Lester M. Crawford. "The FDA will aggressively use the full range of its statutory authorities to prevent the distribution of these potentially dangerous products directly to consumers."
The FDA also is issuing an important alert instructing FDA and Customs officials to automatically detain all decorative contact lenses presented at United States ports of entry. The FDA will seize decorative contact lenses currently on the market in violation of federal law, and is communicating with the public and with the eye-care professional community concerning the dangers of using decorative contact lenses.
Consumers are urged to immediately discontinue use of decorative contact lenses obtained without proper fitting and a prescription, and to notify the FDA of any complaints or problems associated with these products. Telephone and TTY contact information for FDA's consumer complaint coordinators is available via FDA's Web site.
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, FDA, 5600 Fishers Lane (HF-2), Rockville, MD 20850.