FDA Review: 1 of 5 LASIK Patients Suffer Serious Complications
After researching all of the publicly accessible FDA documentation and a large amount of non-FDA literature, including peer-reviewed journals, correspondence between informed parties, and federal court documents, it is my carefully considered opinion that these lasers and associated hardware were respectively PMA-approved and 510(k)-cleared by FDA with egregiously insufficient evidence of their long-term safety and effectiveness for the LASIK indication.
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Posted by Admin at
01:44 AM
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...
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Posted by Admin at
02:05 PM