Shuren Promises Action on Suicidal LASIK Patient

In her email, Cofer told Shuren she had found the patient's 5/22 report in CDRH's MAUDE database, in which the patient said: "I had Lasik 5 years back and it burns like 'profanity'. Feel I should commit suicide, got conjunctivitis and the conditions worsened. I'm fed up, using tears natural and a steroid. Please help."
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Hundreds Petition Congress to Fire CDRH's Shuren

An Internet petition to Congress authored by LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer has drawn more than 270 signatures from across the country in its first 24 hours, demanding the removal of CDRH director Jeffrey Shuren from office.
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Despite Protests, FDA Hangs Tough on LASIK

Despite continued agitation on the part of patient activists claiming injuries from LASIK vision correction procedures, FDA said 9/9 it has "not found any new safety concerns associated with LASIK devices to lead it to believe that there is no longer a reasonable assurance that these devices are safe and effective under the conditions of use in the labeling of the device."
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Attaching 1,073 signatures mostly from other purported victims of LASIK eye surgery, activist Paula Cofer 5/8 asked FDA acting commissioner Stephen Ostroff to reopen for consideration a petition from former CDRH ophthalmic device branch chief Morris Waxler that was denied last summer. The petition sought the market withdrawal of LASIK-indicated device and a public health advisory.
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FDA Panel to Consider Corneal Collagen Cross-linking

As with many regulatory proceedings, a Food and Drug Administration hearing today will have effects reaching far beyond its official topic. An FDA scientific advisory panel is gathering to consider a new treatment for keratoconus, a rare but potentially disabling eye disorder. How the FDA responds could launch a new phase of the Lasik eye surgery boom--with an add-on technology that's marketed as enhancing patient safety but that in fact greatly increases patient risk.
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Device Maker Slammed by Injured Patients at FDA Meeting

Avedro Inc. CEO David Muller was verbally battered by several injured LASIK patients during public presentations 2/24 at a joint meeting of two FDA advisory committees as he led his company's efforts to win an approval recommendation for a new drug/device combination to treat eye disorders progressive kerataconus and ectasia.
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Ex-FDAer Waxler to Oppose Avedro NDA at Advisory Cte.

Former CDRH ophthalmic devices branch chief Morris Waxler will next week oppose an Avedro Inc. NDA seeking approval for riboflavin ophthalmic solutions with UVA irradiation for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus or corneal ectasia following refractive surgery. The venue: the 2/24 joint meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee.
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HHS Investigating FDA's LASIK Life Quality Study

The HHS Office of Human Research Protection (OHRP) has opened an investigation into allegations that the recent FDA/National Eye Institute/Department of Defense LASIK Quality of Life Collaboration Project violated FDA's own regulatory patient informed consent requirements.
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LASIK Activists Petition for Black Box Warning

Notwithstanding a recent FDA-NIH-U.S. Navy collaborative study that downplayed LASIK vision-altering surgery risks, three activists petitioned FDA commissioner Margaret Hamburg 12/24/2014 to add a black box warning to the labeling of lasers approved for the procedure. The petition alleges a "high incidence of induced visual symptoms (double vision/ghosting, starbursts, glare, and halos) and dry eyes" and asks the agency to send letters to professional organizations "to advise physicians of a black box warning on excimer lasers."
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FDA Dims LASIK Harms it Found in 'Life Quality' Study

In a long-awaited report on a collaborative study it conducted on the post-surgical quality of life of LASIK patients, FDA is downplaying the harms it found in up to 45% of 572 patients, adopting the industry-favored term "visual symptoms" vs. the agency's former use of the terms "adverse reactions" or "adverse events."
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