August 16, 2011 Reprinted with permission from www.fdaweb.com LASIK Patients Ask Hamburg’s Help on Deferred Petition 08/16/2011 While CDRH defers a decision on a petition from former staffer Morris Waxler to withdraw the LASIK indication from ophthalmic laser approvals, injured LASIK patients yesterday sent commissioner Margaret Hamburg a 504-signatory petition in support and asking her […]

Reprinted with permission from www.fdaweb.com 2/1/2011 Twenty months after CDRH’s then director of compliance, Timothy Ulatowski, cautioned the nation’s eye care professionals not to make misleading or unsubstantiated claims in their advertisements about the effectiveness of lasers used in LASIK surgery, the Center has conducted no follow-up and last week announced it has no jurisdiction […]

Reprinted with permission from www.fdaweb.com 02/01/2011 Direct from FDA’s “egg on our face” department comes the confession of press officer Karen Riley that she mislaid the answer to our request for clarification about the agency’s jurisdiction/no jurisdiction over “restricted” device advertising, thus missing our deadline. Our story, CDRH Disowns Statutory Authority Over LASIK Ads, attempted […]

01/24/2011 Reprinted with permission from www.fdaweb.com As FDA continues to dither in the face of new data challenging the safety of vision-enhancing LASIK eye surgery, a new report to be published next week by the German technology innovator BioShape Holding will support an immediate ban on the procedure. Adding to data in a petition for […]

Reprinted with permission from www.fdaweb.com 01/06/2011 Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who has publicly said the agency “screwed up” when it approved LASIK vision enhancement lasers on his watch in 1997, petitioned the agency 1/6 to undo that mistake by “withdraw[ing] FDA approval (PMA) for all LASIK devices and […]

11/23/2010 An article titled “Is the Assault on LASIK Justified?” appears in the November, 2010 issue of Cataract & Refractive Surgery Today. This article is essentially an “assault” on Morris Waxler, PhD, former head of the FDA branch responsible for reviewing the original LASIK clinical trials. In typical LASIK industry fashion, the article’s contributors attempt […]

Reprinted with permission from www.fdaweb.com 10/19/2010 A year after announcing a study to determine the percentage of LASIK laser vision-correction patients with significant quality of life problems after having the surgery and to identify predictors of these problems, FDA 10/19 provided an update on its plans for the three-part study that will run until the […]

Reprinted with permission from www.fdaweb.com 9/28/2010 Former CDRH chief of ophthalmic devices Morris Waxler and leading Houston, TX ophthalmic surgeon Stephen G. Slade came to a televised Mexican stand-off 9/28 on the safety and effectiveness of elective LASIK vision correction. After the seven-minute CNN segment, anti-LASIK activists accused Slade of making false statements in it. […]

8/16/2010 The Food and Drug Administration has slapped several more LASIK facilities with warning letters for violations of the medical device reporting (MDR) regulations. Federal law requires surgical facilities to track and report adverse events related to FDA-regulated medical devices such as those used to perform LASIK. Critics of the LASIK procedure have long accused […]