The petition criticizes FDA's "collaboration" last year with the American Society of Cataract and Refractive Surgery to study post-LASIK quality of life. At the time, the society said there had been only 140 dissatisfied comments from patients in the preceding decade. "This number, in contrast to the reported incidence of complications in FDA clinical trials, is a clear indication that LASIK clinics are not reporting LASIK adverse events as required by law," the petition says.
Read more...May 2009 Archives
Injured LASIK patients allege that the LASIK industry has engaged in a cover-up of the frequency and life-altering nature of LASIK complications, such as night vision disturbances and chronic dry eyes, and have consistently ignored MDR reporting requirements. Based on the number of LASIK MedWatch reports which are self-reported by patients, there is compelling reason to believe that most LASIK device user facilities have never filed a single MedWatch report.
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The Food and Drug Administration, which has been investigating patient complaints over the procedure, told healthcare providers that commercials and other promotions that do not convey necessary warnings, side-effects and other precautions are deceptive. "Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading," wrote Timothy Ulatowski, head of the Office of Compliance for the FDA's Center for Devices and Radiological Health.
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FDA acting commissioner Joshua Sharfstein told FDA Webview 5/21 that he is looking into complaints of many LASIK (laser-assisted in situ keratomileusis) eye vision enhancement surgery patients that the agency has failed to honor its commitments to investigate their complaints since 2006 that the technique has unacceptable risks.
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I am seeking an immediate moratorium on the use of excimer lasers for LASIK surgery as there has never been a clinical trial to support the safety guideline of less than 1.0% occurrence of adverse events required by the Food and Drug Administration (FDA) for approval. Approximately 20% of patients in FDA clinical trials for LASIK reported complications (glare, halos, night driving problems, and dry eyes) at six months after surgery which were worse than before surgery, much worse than before surgery, moderately severe or severe.
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The Intralase devices were cleared on the basis of their "substantial equivalence" to a string of six other Intralase 510(k)'d predicates going back to 1999. The study Dupps cited concluded that OBL was associated with thicker corneas and smaller corneal flaps and "did not seem to have detrimental long-term sequelae, although a small harmful effect could not be ruled out." Unlike the ObTape victims, the far more numerous injured LASIK patients support numerous Web sites and have formed networks in which they complain of permanent vision loss and a wide array of sight defects, inadequate or false advice from surgeons before undergoing the procedure, and FDA failure to investigate ambulatory surgical facilities for failure to report adverse events to FDA.
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On March 4, 2009 Pete Burns of Burns, Cunningham & Mackey took the deposition of LASIK surgeon Dr. Jonathan Woolfson in Atlanta, Georgia. Dr. Woolfson was hired by the defense in a LASIK medical malpractice lawsuit. Mr. Burn's posted the following on the firm's website blog: "We represent a lady who had Lasik surgery done on both of her eyes. The surgeon performed the wrong procedure on both of her eyes. This has been a nightmare for her with multiple follow up...
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