October 22, 2002 WASHINGTON (AP) -- The government is cracking down on decorative contact lenses -- from the wild-eyed Halloween look to lenses imprinted with sports logos -- that are sold without a prescription, calling them illegal products that could cause blindness.
The Food and Drug Administration began stopping imports of the decorative lenses at U.S. borders Monday, and said it will seize unapproved lenses sold in convenience stores, flea markets and other spots.
The FDA cites dozens of reports of corneal ulcers -- abrasions that can rapidly lead to vision-threatening infections -- and other eye injuries linked to the products. The agency said that in some cases corneal transplants were required to save eyesight.
Consumers should not wear decorative contact lenses unless they are properly prescribed and fitted by an eye-care professional, the FDA said in a warning issued late Monday.
Decorative lenses have become increasingly popular over the last several Halloweens, but the FDA said its warning wasn't tied just to the upcoming holiday. The agency recently completed an investigation that found widespread illegal sales of decorative lenses along the East Coast -- they are surprisingly popular at beach shops, next to the sunscreen -- and to a lesser extent elsewhere in the country, said FDA Deputy Commissioner Lester Crawford.
People "get the idea since they're out there that they don't pose the same safety issues" as regular contact lenses, Crawford said. "But these things are risky ... so we're taking action for public health reasons."
The FDA has approved the prescription-only sale of some contact lenses for cosmetic use, such as colored lenses, Crawford said. The FDA's approval guarantees the 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.
The agency has never allowed a contact lens to be sold without a prescription, and has debated for months whether it could legally crack down on decorative ones being sold without any oversight.
"These would be very hard to call medical devices," Crawford acknowledged. "But nonetheless they cannot be on the market without some kind of approval."
The FDA urged consumers who have had problems with decorative contact lenses to notify agency offices in their state or call 1-800-FDA-1088.
Copyright 2002 The Associated Press. All rights reserved.
