Dr Morris Waxler PhD (Author) Morris Waxler is a vision scientist, neuropsychologist, and former science manager (Branch Chief) of the PRK/LASIK team at the Food and Drug Administration. He retired from the FDA in 2000. Then he was an FDA regulatory specialist at Hogan & Hartson, LLP (now Hogan Lovells), in Washington, DC and at Godfrey & Kahn, LLP, in Madison, WI. He then formed Waxler Regulatory Consultancy, LLC, which helped medical device companies navigate FDA regulations.
I am a vision scientist, neuropsychologist, and former science manager of the PRK/LASIK team at the Food and Drug Administration (FDA). After retiring from the FDA in 2000 I joined, as an FDA regulatory specialist, the law firm Hogan & Hartson, LLP, now Hogan Lovells, in Washington, DC. Later I continued helping medical device companies navigate FDA regulations at Godfrey & Kahn, LLP, in Madison, WI and then formed Waxler Regulatory Consultancy, LLC which I continued until 2020.
My responsibilities at FDA were vision health, using my expertise to understand the biological effects of optical radiation, and set standards for lasers and high intensity lighting. I first encountered excimer lasers (the lasers used to perform LASIK) at a meeting of the Optical Society of America (1984). I was attending with FDA colleagues, planning a consensus conference on optical radiation and visual health, especially ultraviolet radiation (UV). I heard a lot of buzz about a UV-laser that could etch words into a human hair.
My next encounter with the excimer laser came in 1991, when I was sent on a special assignment from an FDA laboratory to the Division of Ophthalmic Devices, to help resolve serious technical, scientific, and organizational issues. One of my tasks was to review the clinical trial applications for PRK surgery devices, which had made little progress since they were submitted in 1988.
By 1995, after the FDA approved PRK surgery devices and I had become head of FDA’s PRK/LASIK team, I learned some surgeons were using illegal lasers on patients and were even building their own. Then I learned some surgeons were using PRK devices to conduct studies on human subjects without FDA approval.
In 2008, I met Paula Cofer, a LASIK-damaged patient who started a Facebook group where LASIK-damaged patients could get advice and help. Paula introduced me to many patients who had suffered years of poor vision and pain from post-LASIK eye disorders.
I took a second look at the original data submitted to the FDA by the LASIK surgeons from the clinical trials. I realized the catastrophic consequences of only looking at how well patients could read an eye chart. We failed to pick up serious long-term eye disorders, including chronic night vision problems and chronic dry eye, because the number of patients who were tested was small, the tests were insensitive, and the follow-up was short. I was horrified.
I now know they are permanent and devastating. The original data showed that twelve months after the procedure, 60% of patients had fluctuating vision in dim light, 50% had gritty eyes, 40% had sensitivity to light, 20% had fluctuating vision in both dim and bright light, and 15 to 20% had problems driving at night because of glare and halos. See the details in the book.
In 2008 I became a public advocate against LASIK and my consulting business declined dramatically.
On January 6, 2011, I filed a citizen’s petition with the FDA. It is thirty-two pages long. It includes ten figures, six tables, and one hundred and one references from peer-reviewed scientific literature. Every one of my statements is based on scientific research. It is readily available online – simply Google Morris Waxler FDA LASIK.
I concluded the petition by stating: “LASIK risks and long-term consequences outweigh the benefit of reduced dependence on corrective lenses”. I urged the FDA to withdraw its approval of LASIK, issue a Public Health Advisory, and recall all LASIK devices. FDA continues to sell LASIK.