This is the retyped text of a FDA "Talk Paper"

FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

T97-21

June 9, 1997

Sharon Snider: 301-443-3285
Consumer Hotline: 800-532-4440

FDA AUTHORIZES SEIZURE OF UNAPPROVED LASERS

As part of a move to prevent the sale and use of unapproved lasers used in eye surgery, the Food and Drug Administration today requested U.S. marshals seize excimer lasers made by Photon Data Inc., of Winter Park, Fla. The lasers, which were not reviewed by FDA for safety and effectiveness, were being sold to permanently reshape the cornea to treat nearsightedness and other eye conditions.

Approximately nine excimer lasers and components at an estimated value of over $3 million were seized at two Photon Data locations and at a private freight forwarder used by the company.

The sale or use of unapproved excimer lasers is a violation of the law. FDA has been investigating this practice in recent months, and plans to take enforcement action against other unapproved excimer lasers on the market.

FDA is concerned about the potential for serious eye injury from such lasers because the manufacturers have failed to provide the scientific data and information necessary to show that these products are safe and effective for treating patients.

Such information includes success rates, number of adverse events, and critical safety engineering information. Physicians using these lasers may not have enough information to adequately counsel patients about the benefits and risks of treatment.

Recently, the agency's concern has been heightened by reports of serious eye injuries, such as permanently damaged eyesight or temporary blindness requiring a corneal transplant. FDA is currently seeking more information about these injuries. The agency is encouraging patients who have been injured, or doctors who are aware of such injuries, to inform FDA's MEDWatch service by phone (1-800-FDA-1088) or by fax (1-800-FDA-0178).

Only two lasers are currently approved by FDA for refractive eye surgery. They are manufacturered by Summit Technology Inc. of Waltham, Mass., and Visx Inc., of Santa Clara, Calif. Both companies conducted clinical studies to show that their lasers could treat nearsightedness safely and effectively using a procedure called photorefractive keractectomy (PRK). In addition, a Visx excimer laser has been shown to be safe and effective for treating astigmatism. Clinical studies are extremely important in the development of these devices. Through the studies, the manufacturers learn the characteristics of the product, how to fine tune it, how to maximize good results, and how to minimize adverse outcomes such as making vision worse than it was before the patient came in for surgery.

The two approved lasers are clearly labeled with instructions for the practitioners. FDA requires that physicians be trained in their use, and that prospective patients be given a brochure explaining expected and potential problems.

A number of other lasers for eye surgery are currently being tested in FDA-sanctioned clinical studies to determine their safety and effectiveness.

People considering laser surgery for nearsightedness or astigmatism should ask their doctor if the laser being used is an approved Summit or Visx product. If it is not, they should make sure they are being treated with a laser that is part of an FDA-sanctioned clinical study.

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This is the retyped text of a FDA "Talk Paper"

FDA TALK PAPER

FDA AUTHORIZES SEIZURE OF UNAPPROVED LASERS

FDA
TALK PAPER