"It's right there in the record. The agencies and the refractive surgeons, people knew these problems occur and there doesn't seem to be a plan to handle some of the more difficult problems that are created." Reported adverse effects, including cases in which the problems are permanent, include starbursts, halos, glare double-vision, and night blindness.
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After finding that Dr. Nicholas Caro had engaged in unprofessional conduct and gross negligence, the Illinois Department of Financial and Professional Regulation suspended his medical license for 30 days, placed him on probation for a minimum of 3 years and banned him from performing procedures aimed at changing the curvature of the cornea, which includes Lasik surgeries.
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Thomas plans to combat the decline in Lasik (Laser-Assisted In Situ Keratomileusis) procedures by adding new services such as in-depth eye exams, cosmetic eyelash enhancement and, potentially, cataract surgery... "These large Lasik mills have a lot at stake and great incentive to conceal side effects and problems," says Paula Cofer, a Florida woman who has spoken out against the surgery since hers went awry in 2000. "It's all about profit. It's not about treating a medical need. It's an unnecessary surgery."
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But there have been an increasing number of complaints from unhappy patients who say they have experienced significant problematic complications after Lasik. They've been reporting that problems like dry eye, glare, double vision and starbursts (blurring around objects) have impaired their ability to function day-to-day and significantly affected their quality of life, says Dr. Malvina Eydelman of the Food and Drug Administration. In response, the FDA has decided to investigate further...Paula Cofer of Tampa, Fla., has experienced many of these problems.
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Paula Cofer, FDA Patient Representative, served on the April 25, 2008 Ophthalmic Devices Panel in Gaithersburg, MD. The meeting was called to discuss issues concerning post-market experiences with LASIK. Ms. Cofer expressed several concerns about the safety and long-term consequences of LASIK, and asked for changes to the labeling of excimer lasers.
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The FDA has reopened a docket to continue to receive public comments regarding LASIK. Information and comments submitted to the docket will assist the FDA in identifying ways in which the agency can improve its public outreach efforts regarding the risks and long-term consequences of LASIK.
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"The FDA's mission is to serve and protect the public, not to serve industry," says a 126-signatory letter to CDRH acting director Jeffrey M. Shuren, seeking a public health advisory on "the high incidence of adverse events and long-term consequences associated with LASIK surgery."
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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.
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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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