Reprinted with permission from www.fdaweb.com
01/06/2011

Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who has publicly said the agency “screwed up” when it approved LASIK vision enhancement lasers on his watch in 1997, petitioned the agency 1/6 to undo that mistake by “withdraw[ing] FDA approval (PMA) for all LASIK devices and issue a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery.” CDRH is currently awaiting the results of a U.S. Navy LASIK quality-of-life study it commissioned in 2009 that is expected to report at the end of 2012.

In his extensively documented petition, Waxler says the approval was based on data that were “dominated by LASIK surgeons working hand-in-glove with LASIK manufacturers. Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of LASIK devices were the device manufacturers and its collaborators.

“Surgeons used LASIK devices in violation of required manufacturing quality controls (21 CFR 820), patient protections (including but not limited to 21 CFR 50; 54; 56; and 812), and reports of adverse events (including but not limited to 21 CFR 803; 812; and 820) when they manufactured and distributed LASIK devices in interstate commerce within the United States as:

• Homemade lasers (‘black boxes’)
• Imported investigational lasers (‘grey boxes’)
• Illegal key cards (“Bermuda cards”) and
• ‘Off-label’ photorefractive keratectomy (PRK) lasers

“As a consequence,” Waxler’s petition continues, “the FDA was deprived of knowledge of the full extent of LASIK injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devices under 21 CFR 812 and 21 CFR 814.

“In addition, LASIK manufacturers and their collaborators withheld safety and effectiveness information from their investigational device exemption (IDE) reports to the FDA. In addition, they hid LASIK injuries from FDA within the context of out-of-court settlement of innumerable lawsuits. Clinic-sponsored IDE studies cherry-picked, withheld, and hid data from FDA that clearly showed LASIK with excessive adverse event rates (greater than 1%). These activities were an industry-wide effort, organized wholly or in part by the manufacturers and their collaborators in order to circumvent FDA law and regulation. I will submit CONFIDENTIAL information on these matters separately to FDA’s Office of Criminal Investigation.”

Waxler petition says that contrary to FDA’s own device approval standard limiting adverse events to 1%, published scientific data show that LASIK devices induce an average adverse event rate of about 22% “that persists beyond six months to five or more years.”

Moreover, he says, the published data shows that LASIK devices transform healthy corneas into sick corneas that never completely heal; are permanently weakened, vulnerable to trauma and inflammation; cause neuropathic dry eyes, have pathology that progresses annually; are vulnerable to blinding corneal bulging (keratectasia); compromise night vision; have unstable vision corrections that regress; and require eye care that otherwise would not be needed.

“FDA originally counted glare, halos, dry eye, night driving difficulties, and similar problems after excimer laser refractive surgery as adverse events,” Waxler’s petition says, citing the FDA-approved Patient Information Brochure where it says “…adverse events beyond the first few months: night vision difficulty (48.1% at six months)…glare (34.4% at 6 months)…”

Waxler says LASIK manufacturers and their collaborators successfully pressured FDA to classify these problems as mere “symptoms” so that manufacturers could claim that the adverse event rate is less than 1%. “The true adverse event rate six months or more post-LASIK is at least 20 times the FDA approvable rate of 1%,” he says.

Waxler’s petition includes a table showing, he says, that “manufacturers knew that about 43% of LASIK patients’ visual acuity could be improved by wearing spectacles 6-12 months after surgery. The manufacturers and their collaborators distorted this evidence.”