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

Reprinted with permission from fdaweb.com 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 (www.fdaweb.com) 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 […]