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 […]