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-examined 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-ups 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 outcome 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 of 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.