FDA to Hear from Disgruntled Lasik Patients

The agency will ask the panel whether educational materials given to patients need to be changed, to better inform them of the risks. Between 1998, when the devices were first approved, and 2006, the agency received 140 complaints from patients. A large-scale study of patients' quality of life after the surgery has not been done, but the ASCRS will begin work on one soon.If negative publicity emerges from this, it could impact Advanced Medical Optics, Alcon, and Bausch & Lomb, which are the largest players in the laser vision correction devices market.UPDATE: Addressing complaints about Lasik and assessing the quality of life after Lasik surgery will be one of CDRH's biggest priorities in the near future, said Daniel Schultz, CDRH director.UPDATE 2: The panel suggested that FDA strengthen its warnings on the procedure and add more information to its Web site regarding who is not a good candidate for the surgery. The panel said there was nothing wrong with the technology itself.