HHS NEWS

U.S. Department of Health and Human Services 
P98-36                               FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE                Sharon Snider:       301-827-6242 
November 16, 1998                    
                                     Consumer Inquiries:  888-INFO-FDA

FLORIDA FIRM ENTERS CONSENT DECREE WITH FDA;
AGREES TO STOP ILLEGAL SALE OF UNAPPROVED EYE LASERS

A Florida firm whose unapproved lasers used in eye surgery were seized last year at the request of the Food and Drug Administration has agreed today to stop making, selling or distributing unapproved lasers in the United States and also has agreed to the disposition by the government of the seized products.

In a consent decree with the FDA, Photon Data Inc. (PDI), of Winter Park, Fla., agreed to the condemnation of 10 excimer lasers and numerous components valued at nearly $13 million and to the reconditioning of various laser components. The reconditioning will be conducted by the firm under FDA supervision.

The lasers, which have not been evaluated by the FDA for safety and effectiveness, were being marketed for use to surgically correct nearsightedness and other vision problems. The sale or use of unapproved excimer lasers for eye surgery is a violation of the law. FDA has actively investigated this practice in recent years and has seized a number of unapprovedlasers. The agency is concerned about the potential for serious eye injury from the use of unapproved lasers.

PDI has agreed to pay all costs incurred as a result of the disposition of the lasers and reconditioning of components. The laser systems will be disposed of by the government.

The firm has agreed to pay civil fines for potential future violations of the injunction in the amount of $25,000 per violation. The firm has agreed to put $100,000 in escrow to pay such fines. In addition, it has agreed to execute a $100,000 penal bond to insure that they comply with all the conditions of the consent decree.

FDA will monitor PDI's compliance with the consent decree through inspection of its facility.

The consent decree of condemnation and permanent injunction has been filed in the U.S. District Court for the Middle District of Florida, Orlando Division.

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