April 17, 2010

FDA Mismanagement of Lasers Used in LASIK Eye Surgery Described by Former Regulator

Excerpts of a letter from Morris Waxler, a former FDA regulator, to Dean Kantis show how the FDA mismanaged its approval of lasers used in LASIK eye surgery:

LASIK-induced eye injuries occur, in part, because FDA did not ensure that manufacturers have adequate design controls, fault tree analyses, and correction and prevention procedures, including, but not limited to, adverse event definitions, MDR reportable events, trend analysis, and root cause analyses. The agency also did not compare the safety and effectiveness of laser refractive correction outcomes with the safety and effectiveness of glasses and contact lenses so that consumers would have a context for comparison of risks and benefits.  The Center did not conduct a formal risk analysis, or require the manufacturers to submit a formal risk analysis, e.g. sum the error rates due to corneal refraction, topography, thickness, eye length, algorithm accuracy, and the accuracy and precision of the microkeratome. Also FDA did not require worst-case clinical trials or clinical studies representative of clinical conditions of use of LASIK devices. Instead the clinical studies, except for the Kremer studies5, were best-case studies of particular lasers with particular microkeratomes. Then these best-case results were erroneously assumed to be representative of the clinical use of the laser with any microkeratome.  Moreover, the agency decided to regulate microkeratomes as Class II devices even though microkeratomes are clearly an accessory to a Class III device, the LASIK laser.  The agency did not count patient reports of visual problems as primary safety measures, problems such as pain, glare, halo, and night driving problems, even  though reports showed consistent complaints across LASIK devices.  The agency also did not to require labeling of LASIK devices that balanced risks and benefits so that consumers would be adequately informed about the risks of LASIK. The Center did not withdraw a PMA supplement even though the laser manufacturer reported many LASIK induced injuries one month after FDA approval of the supplement.  Furthermore, the agency did not, still does not, use existing authority to reduce the number of LASIK injuries.

Posted by Admin at April 17, 2010 02:05 PM