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Top eye surgery news stories... |
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FDA Review: 1 of 5 LASIK Patients Suffer Serious Complications |
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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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FDA Mismanagement of Lasers Used in LASIK Eye Surgery Described by Former Regulator |
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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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Former FDA Regulator Says LASIK Side Effects Weren't Taken Seriously Enough |
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By Lisa Start, Alberto Orso, Joseph Brownstein LASIK eye surgery has provided the promise of a quick vision fix for millions of Americans, but now one of the Food and Drug Administration regulators who approved the procedure in the 1990s is publicly expressing concerns about its safety. Some 700,000 people a year in the U.S. get LASIK surgery to correct their vision, and in the years since the procedure was approved, the majority of patients have been happy with... |
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Dr. Quentin Franklin and LASIKPLUS Sued for LASIK Malpractice |
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Laurie Shrieves v. Quentin Franklin, M.D., and LCA-Vision, Inc. d/b/a LASIKPlus Virginia Circuit Court for the City of Chesapeake, Case No. CL 10000278-00 Pleasantville, NY (PRWEB) February 14, 2010 -- On February 5, 2010, plaintiff, Laurie Shrieves, filed suit against Quentin Franklin, M.D., and VCA-Vision, Inc., d/b/a LASIKPlus, in the Virginia Circuit Court for the City of Chesapeake, for the negligent performance of LASIK surgery on Ms. Shrieves. On June 29, 2008, Ms. Shrieves came under the care and... |
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Dr. Gerald Horn Charged with Inside Trading by the SEC |
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By Hemma Ramrattan |
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