Jeffrey Shuren Called on to Withdraw FDA Approval of LASIK Devices

FDA Lasik Response to FDA Webview Challenged Reprinted with permission from 09/14/2009 LASIK Surgery Watch says it disputes most of FDA’s response to FDA Webview in our publication of an interview with former FDA Division of Ophthalmic Devices Diagnostic and Surgical Devices Branch chief Morris Waxler, who said that FDA was mistaken in approving […]

FDA to Investigate Deceptive, Misleading LASIK Ads

Reprinted with permission from CDRH to Review 18 ‘Violative’ LASIK Ads 09/11/2009 Responding to a complaint by Florida-based LASIK activist Dean Andrew Kantis, CDRH’s Office of Compliance said 9/11 it would give “appropriate review” to 18 Web site advertisements by LASIK surgery firms that Kantis had gathered and sent to office director Timothy A. […]

Former FDA Official Says FDA “Screwed Up” In Approving LASIK

Former branch chief for diagnostic and surgical devices alleges the FDA caved under pressure from ophthalmologists to approve LASIK devices, despite high incidence of complications. Reprinted with permission from On LASIK ‘We Screwed Up’ Says Ex-CDRH Review Leader 09/08/2009 When it first approved laser devices for LASIK indications in 1998, CDRH “screwed up” in […]

ASCRS’ John Ciccone disavows offensive videos

07-21-2009 The American Society of Cataract and Refractive Surgery (ASCRS) held its convention earlier this year in San Francisco.  At the convention LASIK surgeons performed skits making fun of damaged and suicidal LASIK patients. One skit poked fun at patients who complain of halos and glare after refractive surgery.  The skits were published on YouTube by Parag Majmudar.  One […]

Open Letter to Director Timothy Ulatowski

Open Letter to Director Timothy Ulatowski Posted 7/13/2009 June 27, 2009 Timothy A. Ulatowski, Director Office of Compliance Food and Drug Administration Center for Devices and Radiological Health 9200 Corporate Blvd. Rockville, MD 20850 Dear Mr. Ulatowski, The recent FDA warning to consumers regarding Zicam cold products emphasized the seriousness of loss of smell and […]

LASIK Activist Tells GAO, IG About 20-fold Injury Excess

Reprinted with permission from 6/11/2009 Despite CDRH guidance limiting allowable medical device “complications” to 1%, it has approved lasers used in LASIK vision-correction surgery that exceeded a 20% complication rate in the clinical studies that supported their marketing applications. This is the basis of a 6/11 request by LASIK victim Lauranell H. Burch, who […]

LASIK Patient Advocate Writes Obama Seeking Intervention

Reprinted with permission from FDAWeb Review ( 06/10/2009 LASIK Patient Advocacy Network founder Scott A. Tolchin has written President Obama asking for intervention to help order a moratorium on LASIK eye surgery procedures due to an alleged increased rate of adverse events related to the procedure. Tolchin’s letter notes that patient advocates are planning a […]

LASIK Victims Ramp Up Protests at FDA, Capitol Hill

Reprinted with permission from 06/03/2009 In a battery of new letters to FDA and its Capitol Hill overseers, protesters who say they have been permanently damaged by LASIK vision-correction surgery escalated their campaign this week to have the agency upgrade patient disclosures and warnings in the labeling of devices used and initiate inspections at […]

Citizen Petition to Inspect LASIK Clinics Filed With FDA

Posted 5/26/2009 Petitioner calls for inspection of LASIK clinics, sanctions for clinics that fail to report complications. May 25, 2009 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Dr. Margaret A. Hamburg Commissioner of U.S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Dr. Joshua […]