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# AdvaMed Tells FDA to Scrap LASIK Labeling Guidance
- URL: https://www.fdaweb.com/advamed-tells-fda-to-scrap-lasik-labeling-guidance/
- Published: 2022-11-15T12:00:00.000Z
- Updated: 2026-09-14T18:06:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153204

AdvaMed says FDA should withdraw its draft [guidance](https://www.fdaweb.com/guide-on-lasik-patient-labeling-recommendations/) on LASIK patient labeling recommendations because the group has numerous concerns about the document. The guidance was issued to help ensure that information is available to patients and healthcare professionals about the benefits and risks of LASIK devices that are used in vision correction.

In [recent comments](https://downloads.regulations.gov/FDA-2022-D-1253-0280/attachment%5F1.pdf?ref=fdaweb.com) to FDA, the medical device lobbying group urges the agency to engage in a “collaborative effort to develop consensus patient information that takes the patient-physician relationship into consideration, is balanced, and includes both the benefits and risks of LASIK procedures. It will be essential to include ophthalmic medical societies, including but not limited to the American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS), to provide current and up-to-date data and advice on the patient-physician relationship and to participate in the development of a single informed consent form which is the purview of clinicians and/or their associated facilities.”

AdvaMed says the “underpinnings of this draft guidance are unclear,” and it cites a September denial letter of a citizen petition that sought a black box warning as evidence that the labeling of the devices is adequate. In the denial, FDA explained that it “determined ... that the approved labeling for LASIK products effectively communicates risks associated with the device,” the group emphasizes.

“In proposing very detailed and prescriptive patient labeling that extends well beyond the scope of individual approvals,” the group continues, “the draft guidance therefore appears either to contradict FDA’s stated position in the response to the citizen’s petition on the safety and effectiveness of approved excimer laser systems, or otherwise seems implicitly to propose a new requirement beyond the safety and effectiveness standard.”

AdvaMed also says that because the draft guidance recognizes that excimer laser systems do not require adequate directions for lay use, “there is no clear rationale for attempting to so closely control the scope and nature of information provided to patients, or to dictate and verify communications between doctor and patient. Notwithstanding the shared goal of better-informed patients, certain aspects of these recommendations not only contradict specific device approvals, but they appear to extend beyond FDA’s purview.”

Additionally, AdvaMed notes that according to FDA’s database, there has been a “consistent reduction” in Medical Device Reports associated with refractive laser systems since 2018 and it is unclear why the agency feels the need to issue the draft guidance now. “If FDA believes that refractive excimer laser systems are safe and effective and has concerns that patients are not receiving important information on the LASIK procedure from clinicians,” the group continues, “the forum most likely to achieve FDA’s objective is the development of a preferred practice pattern (standard of care) for LASIK procedures that is led by professional ophthalmic societies such as AAO and ASCRS.”

Meanwhile, adverse events related to LASIK and other laser eye surgeries have been a contentious issue for years. After more than a [decade of stonewalling injured patients’ complaints](http://www.fdaweb.com/login.php?sa=v&aid=D5112693&searchWords=LASIK%20Waxler%20adverse&cate=S&stid=%241%248P5.v.3.%24yrra7%2FTeHKPg9oTPtDtRk%2F) about adverse reactions, CDRH in 2018 lifted their hopes for a change of heart at a one-hour meeting — then dashed them five days later in a statement that doubled down on the agency’s existing position: LASIK is safe and effective for nearly everyone. At issue in the long-simmering controversy is the level of adverse effects that should be tolerated — FDA accepts the industry claim of less than 2% while the patient group cites PMA data showing rates as high as 20%, pointing out that for a medically unnecessary, elective cosmetic procedure it should be close to 0%. LASIK marketers promote the procedure as an alternative to wearing glasses.

**Morris Waxler**, the since-retired CDRH branch chief who approved the LASIK indication for the devices and led the patient group that met with CDRH, said the devices produce “2% catastrophic problems and 20% chronic daily pain and vision distortions.” FDA is “trapped by the facts and owned by industry,” he told ***FDA Webview*** in an email after the meeting.

In 2019, Waxler told CBS News that approving the device was a mistake and LASIK should be taken off the market. “I reexamined the documentation … and said, ‘Wow, this is not good,” Waxler [told](https://www.cbsnews.com/news/lasik-eye-surgery-retired-fda-adviser-says-procedure-should-be-taken-off-market/?ref=fdaweb.com) the network. He said his own analysis of industry data shows complication rates between 10% and 30%.