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Medical Forum / General / Vision / June 2005Altered and Counterfeit LASIK Laser Use Exposed
"An investigation by USAEyes.org has affirmed that an undetermined number of US surgeons (apparently less than 10) have circumvented safety restrictions by hiring third-party vendors to fundamentally alter their excimer lasers to perform LASIK, IntraLASIK, PRK, LASEK, Epi-LASIK and similar refractive laser eye surgery procedures beyond the parameters determined by the United States Food and Drug Administration (FDA) to be safe and effective. These alterations are not approved by the FDA, nor are they sanctioned by manufacturers. It is estimated that approximately 5,000-10,000 patients have surgery with an altered laser each year, however USAEyes.org has found no evidence that indicates patients have been physically harmed specifically due to the use of an altered laser." http://www.usaeyes.org/counterfeit_lasik_lasers.htm Glenn Hagele Executive Director USAEyes.org "Consider and Choose With Confidence" Email to glenn dot hagele at usaeyes dot org http://www.USAEyes.org http://www.ComplicatedEyes.org I am not a doctor. OK, I'll bite. In the PRK, pre-LASIK days, any non-approved laser was considered a "black box," and confiscated. I presume this falls into the same category. However, one should note that the FDA has neither the charter nor the funding to guarantee that the way the laser is used is ultimately safe, even within the specified parameters. For example, prescribing aspirin for a headache that was caused by an intracranial hematoma is malpractice, even though aspirin is an FDA OTC product. I'm not sure what law is broken if a surgeon puts a 6.5mm ablation zone on a -9 diopter eye with an 8.5mm pupil with an FDA-approved laser. Even though most patients do not complain to their surgeons, I think a whole lot of harm is being done to the visual welfare of the public by creating permanently highly aberrated eyes as a general practice. But, I agree that strict enforcement of the law is paramount in this business, and I applaud CRSQA for taking the lead on this issue. The next step would be to go where the FDA fears to tread. DrG Black box lasers are a little different than this. A black box laser is a laser that had never sought approval from the FDA, nor was it manufactured by a respectable company that had received FDA approval for similar devices. In this case, these lasers are either imported from where they are approved, or they are US lasers that have been altered. Off-label use is when a device approved for one procedure is used for another, and is medically appropriate. This is NOT off-label use. The moment that these lasers are imported or altered, they are no longer an approved device. Because they are not an approved device, they cannot have an on-label use, therefore they cannot have an off-label use. Funding restraints notwithstanding, it is the FDA's responsibility to police the use of inappropriately altered excimer lasers. Hopefully our efforts to give this greater attention will put a fire under their bureaucratic tails. Glenn Hagele Executive Director USAEyes.org "Consider and Choose With Confidence" Email to glenn dot hagele at usaeyes dot org http://www.USAEyes.org http://www.ComplicatedEyes.org I am not a doctor. |
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