Morris Waxler, Ph.D., is the former U.S. Food and Drug Administration (FDA) official in charge of approving laser vision correction (LASIK) devices between 1996-2000. In response to pointed questioning by LASIK-injured patients, Dr. Waxler re-examineded the data FDA used to approve LASIK devices as well as the data from subsequent scientific studies. He now concludes that LASIK risks and long-term consequences outweigh the benefit of reduced dependency on corrective lenses, even with newer LASIK surgical technologies such as wavefront custom LASIK and bladeless LASIK.
According to Dr. Waxler, small numbers of patients and short-term follow-up in FDA-required clinical trials for LASIK led to failure to detect serious problems. The FDA looked at how well patients could read the eye chart in the short-term but dismissed troubling surgical effects such as persistent night vision problems and chronic dry eyes.
Dr. Waxler’s research uncovered alarming, new facts about LASIK. Medical research not readily available to the general public consistently shows that the LASIK flap never heals and may be accidentally dislodged for the rest of a patient’s lifetime; that the cornea is permanently weakened and may deform (develop ectasia) weeks, months, or years later, leading to vision loss; that corneal nerves which stimulate tear production are severed and destroyed during LASIK, and that these nerves never fully recover — potentially leading to permanent dry eye disease; that having LASIK causes problems in the future for glaucoma screening and cataract surgery — prompting the FDA to recommend that LASIK patients obtain a copy of their LASIK medical record; that visual quality at night is permanently reduced after LASIK, even when the patient has 20/20 or better daytime vision; and that visual outcomes of LASIK decline over time.
In hindsight, Dr. Waxler believes that the FDA erred in approving LASIK in an environment of enormous pressure from LASIK industry representatives working hand-in-glove with FDA reviewers. In his communications with injured LASIK patients, Dr. Waxler found a pattern of diminished quality of life, depression, and even suicidal-ideation, leading to his reversal on LASIK and the filing of a petition with the FDA calling for an end to LASIK.
In fact Dr. Waxler has called for a criminal investigation.
Dr. Morris Waxler, former FDA regulator, speaks to ABC News, says FDA should take steps to stop what he calls “the epidemic of permanent vision problems” caused by LASIK. Waxler said 50% of LASIK patients experience side effects and 1/3 continue to need glasses or contacts.
MSNBC interview of Morris Waxler, PhD, on 2/18/2011. Dr. Waxler is the former head of the FDA branch responsible for reviewing the clinical trial data on LASIK, and played a role in the original review and approval of LASIK devices. When LASIK was first approved, the FDA relied on small patient populations and short-term data. Now, based on long-term LASIK data and new LASIK clinical studies, Dr. Waxler is urging the FDA to withdraw the approval of LASIK devices due to an unacceptably high adverse event rate, which he says was withheld from the FDA.
Canadian TV, Global News, 16:9 The Bigger Picture, investigative news report on LASIK eye surgery. Investigators go undercover to expose the lies that LASIK clinic staff tell prospective patients. Former FDA chief, turned whistleblower, Morris Waxler, PhD, exposes the dirty secrets of LASIK clinical trials and the egregious FDA approval of LASIK devices. Young mother talks about suffering from painful, chronic dry eyes after LASIK. Son of police officer who took his own life due to LASIK complications speaks publicly for the first time.
*A 2007 review of data from FDA clinical trials for LASIK devices, including newer custom wavefront technology, demonstrates that approximately 20% of patients report dry eyes and night vision problems persisting beyond six months after surgery.