F.D.A. Vows Crackdown on Lenses

By SHERYL GAY STOLBERG

r. Thomas E. Steinemann, a Cleveland ophthalmologist, has seen his fair share of patients with tragic eye disorders. But few have been sadder, he said, than the teenager whose vision was permanently damaged last year by a pair of contact lenses she wore solely to change the color of her eyes.

"Her normal eye color is brown," Dr. Steinemann said. "She wanted green eyes to coordinate with an outfit."

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The patient bought the lenses from a video store, without a prescription; Dr. Steinemann said he was shocked. He complained to the Food and Drug Administration, which last week warned consumers against wearing decorative contact lenses without a proper fitting and a prescription, and said it would crack down on their sale.

"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 an eye care professional," Dr. Lester Crawford, the deputy commissioner of the food and drug agency, said in a statement.

Contact lenses that do not improve vision, called plano lenses by ophthalmologists, have been around for years. They come not only in colors but also patterns: zebra stripes, swirls, cat eyes, sunbursts.

The problem, experts say, is not the lenses themselves, but the people using them — preteenagers and teenagers who are buying them without prescriptions, and so without proper instruction in how to insert and care for the lenses. Studies show the risk of eye infection increases sevenfold for people who sleep in their contact lenses. The risk also increases when lenses are not properly sterilized.

"We're seeing abrasions from the lenses and lens overwear, which can cause ulcers," said Dr. Richard Leung, an ophthalmologist in San Diego. "One concern I have is that because they are a novelty, kids are sharing the lenses. That's a real problem."

F.D.A. officials say their investigation into decorative contact lenses began several months ago after a British company, Fashionwear Services, announced it intended to sell its decorative lenses in this country over the counter. The company said it was already doing so in Britain.

With the consent of major manufacturers, the F.D.A. regulates all contact lenses as medical devices, a classification that requires the lens makers to submit to the agency's stringent review before marketing. But Fashionwear Services argued that because its lenses did not correct vision, they were cosmetics, and therefore not subject to such strict regulation.

The agency responded by looking into the decorative lens market. Investigators found the lenses were being sold freely, without prescriptions, over the Internet and in novelty shops. Dr. Crawford said "numerous cases" of injuries had been reported, including some that led to cornea transplants.

Among them was Dr. Steinemann's patient, who wore her green lenses just once, to a party one night in September 2001. When she saw Dr. Steinemann the next morning, her eyes were red and oozing pus from a bacterial infection. Dr. Steinemann put her in the hospital for "intensive antibiotic therapy." She spent four days in intensive care.

The girl suffered permanent vision damage, Dr. Steinemann said, when scar tissue developed on her cornea. In June, he performed a transplant. "She has done very well," Dr. Steinemann said, "but she still has a long way to go."

A lawyer for Fashionwear Services, Paul Hyman, did not return calls.

Dr. Steinemann's case and others helped convince the F.D.A. that decorative lenses sold over the counter posed a danger. Even so, rather than lose a case in court, the agency felt forced to concede that Fashionwear Services was marketing cosmetics.

But the F.D.A. has notified Fashionwear Services that under the agency's authority to regulate cosmetics, it insists that the company demonstrate that its product poses no risk. The agency also issued a broad warning: any contact lenses being sold over the counter would be seized, as would those imported without F.D.A. approval.