The FDA last month shot down a petition filed by the former staffer who approved Lasik eye surgery, saying the evidence presented in the petition isn’t strong enough to justify revoking pre-market approval and initiating a recall.

Morris Waxler led the FDA team that approved the Lasik procedure, in which an excimer laser is used to change the shape of the cornea to treat myopia and astigmatism. But in 2011 Waxler filed his petition and launched a high-profile publicity campaign accusing the agency and Lasik companies of under-reporting adverse event data and the long-term risks of the procedure.

In a July 23 letter the FDA released August 15, deputy director for policy Nancy Stade of the Center for Devices & Radiological Health said Waxler’s evidence is lacking.

"[T]he information presented to the agency in your petition does not satisfy the statutory requirements for the agency to withdraw approval of the PMA applications for Lasik excimer lasers. Further, in our continued assessment of the literature and medical device reports, we have not found any new safety concerns to lead us to believe that there is no longer a reasonable assurance that these devices are safe and effective under the conditions of use prescribed, recommended, or suggested in the labeling of the device," Stade wrote. "Additionally, FDA does not believe that a public health advisory with a voluntary recall of Lasik devices is warranted."

"[W]e have not found any new safety concerns associated with Lasik devices, the risks associated with each Lasik device are described in the patient labeling, and FDA’s Lasik website provides information about the devices and the procedure, including a summary of the most common risks and links to the Summary of Safety and Effectiveness Data (SSED) and patient labeling for each approved Lasik device," Stade added.