Lasik Vision Institute, Carmel, IN (10/9) Misbranded: FDA determined that the facility is a medical device user facility that is subject to the statutory reporting requirements of the Medical Device Reporting (MDR) regulation. The facility failed to develop, maintain, and implement written MDR procedures, etc. (ophthalmic laser); FDCA 502(1)(2), 519, 21 CFR 803.
Read more...October 2009 Archives
LASIK Surgery Watch (LSW) says FDA should recall laser keratome devices used for LASIK flap recreation due to its negligence in clearing them without rigorous clinical trials. In a 10/10 letter to CDRH Office of Device Evaluation (ODE) director Donna-Bea Tillman, LSW cites a 10/14/08 letter from CDRH scientists and physicians to Rep. John Dingell (D-MI) on abuse of the 510(k) program by clearing devices that were never evaluated for safety and effectiveness.
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FDA says it has issued Warning Letters to 17 LASIK ambulatory surgical centers after recent inspections revealed that they had inadequate systems for reporting adverse events related to the vision correction surgery. FDA has recently ramped up its enforcement efforts, and CDRH compliance director Timothy Ulatowski publicly predicted that this week will be a "Warning Letter Event." The agency says additional inspections of ambulatory surgical centers are pending.
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The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers... The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending.
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Read letter to Dr. Bruce Cassidy, Dr. Elizabeth Serrage, Dr. Jordan Sterrer, and Dr. William Holt of Eyecare Medical Group, Portland, Maine from LASIK patient, Natalie Messier.
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Take the case of LASIK vision enhancement patients who say they were denied informed consent by their surgeons and consequently suffered disabling permanent injuries from devices that the FDAer in charge at the time now says in retrospect should not have been approved for that procedure. As thousands of eye surgeons around the country continue to violate FDA cautions issued last May, the agency says only that it will give "appropriate" review to their promotional activities and declines to say whether it will investigate ambulatory surgical facilities for compliance with Medical Device Reporting (MDR) requirements for adverse events. "FDA can neither confirm nor deny the existence of an investigation," its press office repeatedly says.
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