Dr. Morris Waxler, who as a federal health official was instrumental in approving laser eye surgery as a quick fix to replace glasses or contact lenses, then backtracked a decade later after concluding that the operation could actually affect a patient's vision, died Jan. 2 at a hospital in Madison, Wisconsin. He was 88 years old.
The cause was a stroke, said his wife, Carolyn Zahn-Waxler.
From 1996 to 2000, Dr. Waxler led a government team that evaluated and tightened the clinical and engineering standards imposed on laser devices marketed for surgery. In 1999, he oversaw the original approval of those devices, which were subsequently used for Lasik surgery in the United States.
Patients who had undergone Lasik surgery soon began complaining to him personally, he said in a 2011 petition to the U.S. Food and Drug Administration, about how their vision had been distorted by halos, dryness and excessive glare; his night vision was impaired; and that chronic pain contributed to depression and even suicide.
After Waxler decided to review the original data presented by the Lasik surgeons, according to Dr. Cynthia MacKay, a professor of ophthalmology at Columbia Presbyterian College of Physicians and Surgeons, who campaigned with Waxler to end Lasik, “he discovered that what the surgeons had claimed were 'temporary and treatable side effects' were actually devastating, untreatable and permanent complications.”
In 2010, a decade after retiring as section chief of the U.S. Food and Drug Administration's Center for Devices and Radiological Health, Dr. Waxler had admitted that he had made a mistake with the procedure: that there were serious safety problems.
A year later, he unsuccessfully petitioned the FDA to issue a public health advisory to warn patients about the potential harmful effects of Lasik and to remove the devices from the market. He noted that “many thousands of eyes have been irreparably damaged by LASIK devices since the 1990s” and noted the close relationship between surgeons and device manufacturers.
“Beginning with my tenure, FDA decision-making on LASIK devices was dominated by LASIK surgeons working hand-in-hand with LASIK manufacturers,” Dr. Waxler wrote in his petition. “The data that recently came to light expose this association for what it was: a classic example of the fox guarding the henhouse, in which the primary arbiters of the safety and effectiveness of LASIK devices were the device manufacturers and their collaborators.”
“As a result,” he added, “the FDA was deprived of knowledge of the full extent of Lasik injuries before and during FDA reviews of documents submitted in support of the safety and effectiveness of Lasik devices.”
In 2012, he continued to sound the alarm, writing in a public letter: “I have come to believe that the real risks associated with these devices are much greater than what the FDA would have originally approved, had important data not been distorted or withheld.”
In 2014, it asked the FDA to reconsider its original request. But he again denied it, disagreeing with his claim that the “FDA did not adequately consider the industry's history of prolonged pressure on the Agency or use the correct data to assess the risks of Lasik devices.”
The agency told The Times this week that it is “working to collaborate with our stakeholders to determine the most appropriate path forward to communicate LASIK-related risks to patients and healthcare providers.”
Although most studies point to high levels of success after Lasik, including a widely cited 2016 report that found vision of 20/40 or better for 99.5 percent of patients, critics maintain that evaluation of the surgery must meet a higher safety standard than other medical procedures because it is elective.
“There's nothing wrong with the eyes of a person who has Lasik,” most importantly, as Dr. Waxler told CBS News in 2019. “They have healthy eyes. They could go and get a pair of glasses.”
Morris Waxler was born on January 25, 1937 in Washington, DC, the son of Jewish immigrants from Russia. His father, Isadore, was an antique dealer and cabinetmaker. His mother, Fannie, whose maiden name was also Waxler, was an accountant and managed the household.
After graduating from high school and serving in the Coast Guard, he studied psychology at Howard University and received a bachelor's degree in 1962 and a master's degree in 1964. He earned a master's degree in neuroscience from Michigan State University in 1966 and a doctorate in psychology from the University of Maryland in 1977.
After retiring from the FDA, he worked for two law firms and then established a consulting firm, Waxler Regulatory Affairs, in Madison.
In addition to his wife, whom he married in 1967, he is survived by a daughter, Rebecca Waxler Ramsey.
In 2024, Dr. Morris wrote a book about his anti-Lasik crusade, “The Unpleasant Truth of Laser Vision Correction: LASIK Surgery Makes Healthy Eyes Sick,” which also included stories from Paula Cofer, founder of a support group for Lasik complications; Dr. Edward Boshnick, who spent more than two decades caring for patients with eyes damaged by Lasik; and Dr. MacKay.
“Even if it's 2 percent who are at risk for sight-threatening problems, that's thousands of people who are at risk each year,” Dr. Waxler told The Times in 2018. “What is an acceptable level of risk when operating on healthy eyes?”
