Aggressive marketing of excimer PRK in the US prior to FDA approval and early reports of irreversible damage to patients with custom excimer lasers is leading to increased regulatory agency actions targeted at the refractive laser "gray market." This underground movement toward acquiring used, modified, or "homemade" excimer laser kits and performing various types of refractive laser surgery on patients without FDA oversight has been gaining momentum as delayed FDA approval of PRK leaves American ophthalmologists far behind their colleagues in other countries where there is access to the latest refractive laser technologies (see Medical Laser Insight, May 1995). Frustration, greed, and rebellion against the US regulatory process created this opportunity for entrepreneurs to satisfy the needs of risk-taking ophthalmologists willing to challenge the federal government and industry forces in legal battles.
Currently, with the assistance of Summit Technology, the FDA's Office of Compliance (enforcement division) is methodically identifying, warning, and visiting users of gray market Summit refractive lasers being imported into the USA. Several new warning letters went out to users and suppliers in August, as the Agency stepped up its enforcement activities in this area. Commenting on this topic at the FDA's Ophthalmic Advisory Panel meeting on July 20, Eric Latish from the FDA's Office of Compliance said, "These physicians performing PRK are opening themselves up for liability under tort law. They are virtually testing their products on unknowing patients. So we are preparing to take some action with respect to that and remove those products from commercial use."
As far as custom laser suppliers are concerned, the FDA has identified at least one of these operators, and cited this company for "failing to meet device registration and listing requirements, and for marketing adulterated and misbranded devices."
In a July 28, 1995, letter to high-profile custom excimer user Fred Kremer, MD, in Radnor, Pennsylvania, the FDA charges him with numerous violations of federal law and threatens "seizure, injunction, and/or civil penalties." This letter is actually a follow up to a site visit by FDA inspectors in September 1994, and a subsequent warning letter issued in March 1995. Although Dr Kremer publishes results on hundreds of patients he has treated using PRK and LASIK, the FDA states that he has never obtained permission from the Agency to perform these procedures under an Investigational Device Exemption (IDE) study.
According to this warning letter, Dr Kremer was personally notified of his violations during a meeting with an FDA representative as recently as April 11, 1995. At that time, the Agency informed Dr Kremer that his laser does not meet all of the requirements for a custom device. Based on review of current promotional letters sent out by Dr Kremer, the FDA charges him with "promoting and using your excimer laser device illegally. You are introducing your device into commerce each time that you use it on a patient." Based on the September 1994 site inspection by investigators, the FDA also disapproved the quality control and testing methods used by Dr Kremer--leading to numerous violations of federal law related to medical device standards.
Finally, the FDA reiterates that Dr Kremer may not legally treat patients until
Dr Kremer is only one of at least two dozen US ophthalmologists using illegal excimer lasers on patients at this time--both "custom" and gray market imports. Reports of surgical disasters with these uncontrolled devices are only unconfirmed rumors, because no ophthalmologist wants to go on record admitting failures. However, a major malpractice lawsuit seems inevitable, with subsequent coverage by the national media. Under these circumstances, we can certainly envision the general public exposed to sensational news stories concerning excimer lasers destroying eyes and blinding patients. If this scenario is allowed to unfold due to unrestrained illegal excimer operators, the consumer's perception of PRK could easily switch from the "miracle of light" to the "nightmare of blindness."
Michael Moretti is the editor of Medical Laser Insight, and president of Medical Insight, Inc, a market research firm specializing in medical laser technology.
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