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Lasik Doctors


FDA to Lasik Doctors: Talk of Risks

"Dear Doctor" letter in response to patient concerns and complaints.


FDA wants Lasik advertising to include warnings.

ROCKVILLE, Maryland, May 22, 2009, /FDA/  -- The US Food and Drug Administration (FDA) has published a "Dear Doctor" letter admonishing Lasik surgeons who do not adequate inform potential patients of the limitations and risks associated with Lasik and other laser vision correction surgery techniques in their advertising.

On April 25, 2008, FDA’s Ophthalmic Devices Panel held a public meeting to discuss issues concerning post-market experiences with LASIK procedures. A representative of the Council for Refractive Surgery Quality Assurance presented the preliminary results of the USAEyes Competence Opinion Relative to Expectation (CORE) Lasik patient survey at this meeting, showing that over 98% of laser vision correction surgery patients would have surgery again, knowing what they know now. See Lasik Results for details.

Both at the meeting and through submissions to a subsequently established public docket, the FDA has received information, comments, and complaints from interested persons regarding the promotion and advertising of LASIK procedures and the FDA-approved lasers used in LASIK procedures. The FDA has received complaints that eye care professionals’ advertisements for LASIK procedures and FDA-approved lasers used for the LASIK procedures failed to inform consumers of the indications, limitations, and risks associated with LASIK procedures and the approved lasers used for the LASIK procedures.

In response, the FDA has asked all doctors to help eliminate "deceptive or misleading health-related advertising claims" as an important part of protecting the public health. See FDA Lasik Advertising Letter

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