Unapproved lasers seized from Florida manufacturer

FDA Consumer, Sept-Oct, 1997

As part of a crackdown on the sale and use of lasers not approved for eye surgery, U.S. marshals, on behalf of FDA, seized nine excimer lasers and components valued at more than $3 million from Photon Data Inc., of Winter Park, Fla.

The lasers, which FDA had not reviewed for safety and effectiveness, were being sold to reshape the cornea to treat nearsightedness and other eye conditions. They were seized June 9.

FDA is concerned about the potential for serious eye injury from unapproved excimer lasers because manufacturers have not submitted success rates, number of adverse events, critical safety engineering data, and other information FDA requires to show the devices are safe and effective. Physicians using unapproved excimer lasers might not have enough information to counsel patients adequately on the benefits and risks of the treatment.

FDA's concern about unapproved excimer lasers has been heightened by recent reports of serious eye injuries from the devices such as permanently damaged eyesight or temporary blindness requiring a corneal transplant. The agency asks patients who have been injured, or doctors aware of such injuries, to inform FDA's MedWatch service by phone, (1-800) FDA-1088; by fax, (1-800) FDA-0178; or by modem (1-800) FDA-7737.

Currently, FDA has approved only two lasers for photorefractive keratectomy (PRK), a surgical procedure that treats nearsightedness. The laser manufacturers, Summit Technology Inc., of Waltham, Mass., and Visx Inc., of Santa Clara, Calif., conducted clinical studies to show that their lasers were safe and effective. (See "Laser Procedure for Nearsightedness" in the Updates section of the January-February 1996 FDA Consumer.) FDA also has approved a Visx laser to treat astigmatism.

Several other lasers for eye surgery are currently in FDA-sanctioned clinical trials.

Patients considering laser surgery for nearsightedness or astigmatism should ask their doctors if the laser is an approved Summit or Visx product. If not, they should make sure the laser is part of an FDA-sanctioned clinical study.

At press time, only the Photon Data devices had been seized, but FDA plans to take enforcement action against other unapproved excimer lasers on the market.