Eye Doctors Told Not to Use Unapproved Lasers to Treat Myopia

Federal regulators issued a warning today to eye doctors not to use unapproved machines for laser surgery on nearsighted patients.

The action is the latest controversy involving the surgical procedure, photorefractive keratectomy, in which a laser burns off bits of the surface of the cornea to flatten it and improve mild or moderate nearsightedness.

The Food and Drug Administration has approved two lasers since last fall, made by Summit Technology and Visx, used in the surgery.But some doctors are importing cheaper, used lasers from Europe, where they have been sold for several years, or building their own, so some patients are undergoing surgery on machines that have not been approved by the agency as safe.

That is illegal, the F.D.A. warned at a meeting of eye specialists today. Doctors either must use agency-approved lasers or, if they think that their own lasers are superior, get Government permission to study them while informing patients that the devices are experimental.

The agency could seize an unapproved machine or get a court injunction to stop its use.

The F.D.A. does not know how many unapproved lasers are being used. Dr. Alpert advised patients to ask their doctors before surgery about the machines they use and their success rates. She also advised that they request F.D.A.-approved patient leaflets and ask to speak with previous patients.

"This, let us be clear, is irreversible surgery," she said. "Wait until you're sure."

But doctors said that they were offering their patients better care than the F.D.A.-approved equipment could provide and that the F.D.A. had no business interfering in their practice of medicine.

"Why did I get involved in nonregulated lasers?" asked Dr. Ralph Berkely of Houston, who built his own laser. "My moral and ethical responsibility to do what I believe is in the best interest of my patients."

If the F.D.A. would speed up its review of new lasers, doctors would not be forced to use "untested techniques," said Dr. Stephen Trokel of the American Society for Cataract and Refractive Surgery.

Some 30,000 eyes have been treated with the technique, but the F.D.A. and the Federal Trade Commission warned doctors last spring against false advertising. Advertisements saying consumers could "throw away your glasses" glossed over the risks, the warning said. While the surgical technique usually works well, sometimes patients need reading glasses or experience glare, hazy vision and other problems.