Reprinted with permission from www.fdaweb.com
FDA-CDRH Delays LASIK Petition Decision
08/09/2011
A seven-month-old citizen petition seeking a safety-based withdrawal of approval for all LASIK eye surgery devices "raises issues requiring further review and analysis by agency officials," according to a 7/7 letter to petitioner Morris Waxler, the former CDRH official who led the devices' review and approval. Signed by Center deputy director for policy Nancy Stade, the letter says FDA has so far been unable to reach a decision, and offers no indication of how long a decision might take. "We will respond to your petition as soon as we have reached a decision on your request," it says.
Waxler filed his petition1/6, after publicly asserting that the agency "screwed up" in approving the devices' LASIK indication, because it was based on data that were "dominated by LASIK surgeons working hand-in-glove with LASIK manufacturers." As a result, the petition said, the data understated the adverse event incidence from 22% to less than 1%.
