United States of America. The Food and Drug Administration has taken action against unapproved excimer lasers that are being used to treat nearsightedness and other eye conditions. Such unapproved lasers pose a risk to patients because their use could potentially cause serious eye injury. The FDA is also urging patients to verify that their laser surgery is being performed only with an approved laser or in an FDA-monitored clinical study.

In the past 3 years, the FDA has issued 24 warning letters to manufacturers and physicians regarding the sale and use of unapproved excimer lasers and has recently initiated seizures of lasers from a manufacturer at three eye clinics after warnings were ignored. Investigations continue and the FDA plans to take further enforcement action.

Only two lasers are currently approved by the FDA for refractive eye surgery, manufactured by Summit Technology and VISX. Both companies conducted clinical studies to demonstrate that their lasers could treat nearsightedness safely and effectively using a procedure called photo-refactive keratectomy (PRK). A number of other excimer lasers are currently being tested in FDA-sanctioned clinical studies.

[See also Pharmaceuticals Newsletter No. 8, August 1996]

Reference: FDA Talk Paper T97-52 dated 22 October 1997.

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