LasikPlus Vision Center, FDA warning letter 4/3/12

APR 3, 2012 WARNING LETTER VIA UNITED PARCEL SERVICE Ms. Casi Cleaveland Regional Director LasikPlus Vision Center 200 Galleria Parkway Suite 200 Atlanta, Georgia 30339 Dear Ms. Cleaveland: During an inspection of your firm located in Atlanta, Georgia, on October 5-6, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that […]

LASIK Founder Files NDA for LASIK Injury-healing Drug

Reprinted with permission from 03/09/2012 David Muller, who as founder and CEO of Summit Technology gained in 1996 the first excimer laser approval for the controversial LASIK vision correction surgical procedure, announced 3/8 the submission of an NDA for VibeX (riboflavin ophthalmic solution)/KXL System to be used in treating corneal damage often associated with […]

Dr. Kim Robbins, MD, Robbins Eye Center complaint

December 31, 2011 On 12/27/2011, the LASIK industry watchdog group, LASIK Surgery Watch (LSW), sent a letter to the FDA’s Center for Devices and Radiological Health requesting “that the FDA take immediate action to stop deceptive and misleading advertising of LASIK by Kim Robbins, M.D.” The letter, addressed to Steven Silverman, Director of the Office […]

FDA Warns Against Illegal LASIK Ads Again

Reprinted with permission from 09/28/2011 FDA Warns Against Illegal LASIK Ads — Again Despite a 5/22/09 letter to eye care professionals cautioning against inappropriate advertising and promotion of FDA-approved lasers used in refractive procedures such as LASIK, FDA says it continues to receive information concerning improper promotion and advertising practices by eye care professionals. […]

LASIK Patients Ask Hamburg’s Help on Petition

August 16, 2011 Reprinted with permission from 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 […]

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 […]