Dr. Morris Waxler, the former Branch Chief in charge of FDA approvals of LASIK devices between 1996-2000, has petition the the FDA commissioner, Dr. Margaret Hamburg, take the following actions:
1. Withdraw FDA approval (PMA) for all LASIK devices
2. Issue a Public Health Advisory with a voluntary recall of LASIK devices
See http://tinyurl.com/4exksuw for details.
FACTUAL GROUNDS
Manufacturers and their collaborators (including but not limited to clinics, refractive surgeons, andagents) withheld and distorted safety and effectiveness data (Section