T97-52 Sharon Snider: 301-827-6242 Oct. 22, 1997 Consumer Inquiries: 800-532-4440 UPDATE ON UNAPPROVED EXCIMER LASERS The Food and Drug Administration is taking 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. FDA is also urging patients to verify that their laser surgery is being done only with an approved laser or in an FDA-monitored clinical study. In the past few months, FDA has asked U.S. Attorneys to initiate seizures of lasers from a manufacturer and at three eye clinics. The manufacturer and eye clinics had all ignored prior warnings from FDA. U.S. marshals have seized unapproved lasers from the following locations: * June 9 -- Photon Data Inc., Winter Park, Fla. -- Nine unapproved excimer lasers and components valued at over $3 million seized at two company locations. * July l -- Woodhams Eye Clinic, Atlanta, Ga. -- One unapproved excimer laser seized from the office of J. Trevor Woodhams, M.D. * August 28 -- Neumann Eye Institute, Deland, Fla. -- One unapproved excimer laser seized from the office of Albert C. Neumann, M.D. * August 28 -- Pro Cargo, Miami, Fla. -- One additional unapproved excimer laser manufactured by Photon Data Inc. seized at this private freight forwarder. * Sept. 2 -- St. George Corrective Vision Center, Chicago, Ill. -- One unapproved excimer laser seized from the office of Nicholas Caro, M.D. In the past three years, FDA has issued 24 warning letters to manufacturers and physicians regarding the sale and use of unapproved excimer lasers. The agency is continuing to investigate this activity and plans to take additional enforcement action. Only two lasers are currently approved by FDA for refractive eye surgery. They are manufactured by Summit Technology, Inc., of Waltham, Mass., and VISX, Inc., of Santa Clara, Calif. Both companies conducted clinical studies to demonstrate that their lasers could treat nearsightedness safely and effectively using a procedure called photo refractive keratectomy (PRK). In this procedure, the surgeon permanently reshapes the cornea by using the laser to deliver bursts of ultraviolet light that vaporize precisely targeted corneal tissue. The effect is to flatten the cornea. In addition, a VISX excimer laser has been shown to be safe and effective for treating astigmatism, distorted vision caused by an uneven curvature of the cornea. Recently, the American Academy of Ophthalmology adopted a policy that lasers should be used for refractive surgery only if the lasers are approved by FDA or are used under FDA-sanctioned clinical studies and are being operated under an experimental protocol approved by an institutional review board. Clinical studies are extremely important in the development of these lasers. Through these studies, the manufacturers learn the capabilities and characteristics of the product, how to fine tune it, how to maximize good results, and how to minimize adverse outcomes. (PRK can occasionally make vision worse than it was before the patient came in for surgery.) Furthermore, clinical studies are important for determining which patients will best benefit from use of the device. Also, during these studies, physicians learn how to perform the surgery to yield the best outcome for the patient. Information obtained during the studies is included on the device labeling when the laser is approved for marketing. The two approved lasers are clearly labeled with instructions for the safe, effective use of the device. FDA requires that physicians be trained in use of the lasers, and that prospective patients be given a brochure explaining expected results and potential problems associated with refractive surgery. A number of other excimer lasers for eye surgery are currently being tested in FDA-sanctioned clinical studies to determine their safety and effectiveness. FDA urges people considering laser surgery for nearsightedness or astigmatism to 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. ####