Morris Waxler

Morris Waxler is the former U.S. Food and Drug Administration official in charge of approving laser vision correction (LASIK) devices between 1996-2000. He is the founder and president of Waxler Regulatory Consultancy, LLC.
Waxler has worked with more than 60 companies to get products approved by the FDA. From 1992 to 1996, he worked as an Interdisciplinary Scientist at the FDA's Diagnostic & Surgical Devices Branch, Division of Ophthalmic Devices.
Waxler founded Waxler Regulatory Consultancy LLC in 2008.
On 6 January 2011, Waxler requested that,
:"the Commissioner of Food and Drugs withdraw FDA approval (PMA) for all LASIK devices and issue a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery."
Waxler alleged that,
:"The FDA was deprived of knowledge of the full extent of LASIK injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devices under 21 CFR 812 and 21 CFR 814. In addition, LASIK manufacturers and their collaborators withheld safety and effectiveness information from their investigational device exemption (IDE) reports to the FDA. In addition, they hid LASIK injuries from FDA within the context of out-of-court settlement of innumerable lawsuits. Clinic-sponsored IDE studies cherry-picked, withheld, and hid data from FDA that clearly showed LASIK with excessive adverse event rates (greater than 1%). These activities were an industry-wide effort, organized wholly or in part by the manufacturers and their collaborators in order to circumvent FDA law and regulation. I will submit confidential information on these matters separately to FDA’s Office of Criminal Investigation."
In an interview with CNN in 2011, Waxler stated that the failure rate, based on FDA data, is over 50%, 18% or more people suffer from glare, halos, dry eyes and similar problems and around 0.7%-1% have problem with corneas so thin that they bulge. He stated that problems such as haze, halos and night driving problems are persistent and they remain after a year. He said that,
:"I was wrong to discount the haze, halos and other effects. These have not been studied extensively and when they are studied, they are studied by people who have financial interest in the outcome and no independent studies have been done."
Godfrey & Kahn
Godfrey & Kahn, a Milwaukee law firm recruited Waxler as the regulatory affairs director in 2002.

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