Within hours of receiving the first "substantive" report of a patient being seriously harmed by one of the "homemade" excimer lasers being used by a small number of refractive surgeons in the US, the Chief of the FDA's Dental, ENT, and Ophthalmic Devices Branch, Eric Latish, could be found working late at FDA headquarters, meeting with his superiors and beginning an intensive investigation. The report was filed in September by a respected physician and may well expedite and intensify FDA action against what the agency has already determined to be "illegal" excimer laser devices.
"We do have substantive information that there was an injury," Latish told the Journal of Refractive Surgery within hours of receiving the complaint. "Whether the injury was directly related to the laser versus technique versus some other occurrence in the operating room, we do not know and are now investigating."
The report involves a 32-year-old female patient who was functionally blind more than 3 months after undergoing simultaneous bilateral LASIK with a "custom-made" non-FDA-approved excimer laser. Laser refractive experts familiar with the case say the damage done to the patient's eyes was directly related to problems with the laser. Instead of the energy being distributed over the entire ablation zone, it was concentrated in one small spot.
What resulted was a 1- to 2-mm optical zone with an estimated ablation depth of 400 µm, creating a pit, which is extremely hard to correct.
Three months after the initial LASIK, the patient was capable only of finger counting, at a time when most postoperative LASIK patients have reached their intended correction and stabilized. In an attempt to restore visual function, surgeons reshaped the corneal beds using ALK techniques and subsequently performed a lamellar keratoplasty on the right eye. The patient is now able to read and drive but still has a loss of visual acuity.
Up until this time, the FDA admitted it was moving slowly in its investigation of the lasers, in part, because it had received no solid reports of any patients being harmed by the "illegal" devices. The FDA had received only what it called "anecdotal" or "third-party" complaints. The official September report changed all that.
Within hours of the report to the FDA, the agency's national headquarters was contacting field investigators in the region where the incident is alleged to have happened. Those investigators began a series of interviews expected to include the physician who filed the complaint, the surgeon who performed the procedure, all members of the operating room staff, and "anyone else who was involved who can shed some light on the situation to help us make a determination as to how or why the problem occurred," said the FDA's Latish. "Often complaints of injury are difficult to pin down because of the various possibilities of cause. Was it human error or a malfunction? It is not always easy to determine." The investigation could take weeks to complete while the laser involved in the case continues to operate.
The FDA sent several warning letters in July and August informing physicians, using so-called "custom" excimer lasers that their lasers were illegal and that continued use could result in court injunctions, civil penalties up to $15,000 per violation, and seizure of the device. Recipients of those warning letters were given 15 working days to respond, but when that deadline passed, there were no reports of any of the lasers being voluntarily removed from service.
The warning letters signaled the beginning of what the FDA has called a tougher stance against the non-approved lasers. "We do not issue a warning letter unless we believe there is a violation and we will take the next logical step if there is noncompliance," Latish said.
The next logical step would typically be seizure of the lasers and court injunctions against those firms building the devices, actions that could take less than 1 month to complete, but which are not made public until after the seizure has occurred.
The FDA says its initial actions were slow because the agency was conducting the research necessary to make certain it was on solid regulatory ground. But now that the research has been done, the devices formally declared illegal, and a substantive report of patient injury received, FDA officials say more intensive scrutiny and legal action against those found in non-compliance will be forthcoming.
Lisa A. Kearns investigates and reports industry news for The Journal of Refractive Surgery.
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Copyright 1995, SLACK Incorporated. Revised 17 November 1995.
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