CDRH Disowns Statutory Authority Over LASIK Ads 01/31/2011

Reprinted with permission from 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 […]

LASIK Mystery Solved: FDA ‘Declassifies’ Secret Ads Policy

Reprinted with permission from 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 […]

Why LASIK is ‘Too Dangerous to be Allowed’ — German Firm

01/24/2011 Reprinted with permission from 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 […]

FDAer Who OK’d LASIK Petitions for Revocation

Reprinted with permission from 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 […]

Is the Assault on LASIK ‘Critics’ Justified?

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 […]

FDA Outlines ‘Secret’ LASIK Study Details

Reprinted with permission from 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 […]

x-FDAer Waxler, Eye Surgeon Spar on CNN Over LASIK

Reprinted with permission from 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. […]

FDA Issues Additional Warning Letters to LASIK Clinics

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 […]

FDA Lacks Transparency in LASIK Investigation

Reprinted with permission from 05/25/2010 Oil Spill Has a Lesson for FDA: Federal Impotence [Analysis by Jim Dickinson*] Some sides see it as that old Washington blame game — the Gulf of Mexico oil spill is “Obama’s Katrina.” That may be so, but nevertheless, there is a sobering message for FDA in this disaster. […]

Former FDA LASIK Chief Calls Clinical Trial ‘Unethical’

Reprinted with permission from 05/07/2010 Former CDRH chief of ophthalmic devices Morris Waxler, who was in charge of evaluation LASIK devices approved between 1996 and 2000, told the American Society of Cataract and Refractive Surgeons (ASCRS) 5/7 its proposed Phase 2 keratectasia trial on LASIK effects is unethical and “I will do everything I […]