Reprinted with permission from fdaweb.com
LASIK Surgery Watch (LSW) says FDA should recall laser keratome devices used for LASIK flap recreation due to its negligence in clearing them without rigorous clinical trials. In a 10/10 letter to CDRH Office of Device Evaluation (ODE) director Donna-Bea Tillman, LSW cites a 10/14/08 letter from CDRH scientists and physicians to Rep. John Dingell (D-MI) on abuse of the 510(k) program by clearing devices that were never evaluated for safety and effectiveness.
LSW also tells Tillman it was “pleased to learn of your personal effort as director of the Office of Device Evaluation at FDA to address ‘integrity’ problems of the beleaguered 510(k) program.”
It asks that ODE review the appropriateness of the 510(k) approval process for femtosecond ophthalmic laser keratomes, which have been cleared as substantially equivalent to predicate IntraLase lasers that were approved as substantially equivalent to a metal blade keratome and an obsolete dissimilar ophthalmic laser.
“While the intended use of both blade and laser keratomes is to create a flap in the cornea, technological characteristics of these two devices are not similar as required under 510(k) guidelines,” the letter says.
LSW says that an obvious omission in the marketing of all-laser LASIK is the new technology’s “spectrum of new complications” that were never encountered with blade keratomes. The group says that peer-reviewed literature of IntraLase LASIK reveals numerous reports of complications unique to laser keratomes, as well as flap complications similar to those associated with metal blade keratomes. And it says that FDA’s MedWatch shows complications associated with laser keratomes, including some that are unique to the device. But LSW claims that the true incidence of IntraLase complications isn’t known due to the widespread failure of LASIK surgeons to file adverse event reports and the ignorance of affected consumers that they can file their own reports.