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# Ex-FDAer Waxler Challenges Safety of Eye Laser Procedure
- URL: https://www.fdaweb.com/ex-fdaer-waxler-challenges-safety-of-eye-laser-procedure/
- Published: 2019-01-31T12:00:00.000Z
- Updated: 2026-09-15T00:59:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143275

Retired CDRH branch chief **Morris Waxler**, who approved the original LASIK vision correction indication, is urging the Center to stop deceiving the public about adverse events (AE) associated with a laser procedure called the small incision lenticule extraction (SMILE) that is intended to reduce or eliminate nearsightedness in certain patients 22 years of age or older. SMILE was [approved in 2016](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm520560.htm?ref=fdaweb.com) for Carl Zeiss Meditec’s VisuMax Femtosecond Laser.

The device removes a small amount of eye tissue to permanently reshape the cornea, according to an agency [news release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm520560.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) announcing the approval. “A femtosecond (very fast, short-pulsed) laser makes cuts within the cornea, creating a disc-shaped piece of tissue that is removed by the surgeon through a small incision in the surface of the cornea,” it says. “This tissue removal causes the shape of the cornea to change, which corrects the nearsightedness.”

According to a 1/30 email to CDRH Ophthalmic and Ear, Nose and Throat Devices director **Malvina Eydelman**, Waxler says the agency’s approved labeling deceptively says that “No AE occurred at a rate of 1% or greater per type of event.” He says this statement is true only for the agency’s “narrow definition of adverse events as loss of distance acuity greater than 20/40\. In addition, your statement is limited to ‘per type of event,’ falsely assuming SMILE does NOT induce multiple eye problems simultaneously. In fact you know that SMILE simultaneously weakens healthy eyes, distorts corneal shape, and induces multiple ocular pathologies. You deceptively understate the risks by not cumulating complication rates for different types of events.”

Additionally, Waxler takes issues with SMILE approval documents where FDA “falsely” states “The potential risks are mitigated by the labeling.” He said such a statement is deceptive because the approval does not require patients to receive any labeling, and the agency allows the use of misleading “informed consent documents,” among other issues.

Waxler’s email to Eydelman noted that TV meteorologist **Jessica Star** took her life in December ([see story](https://www.freep.com/story/money/business/2018/12/18/meteorologist-jessica-starr-suicide-lasik-questions/2335467002/?ref=fdaweb.com)) because of complications she experienced after SMILE surgery. “I represent thousands of people injured because of your deceptions,” he said. “Tell the public the true complication rates.”