File a report with the FDA for problems related to LASIK
MedWatch is the FDA's program for tracking medical device-related adverse events, which includes LASIK problems. The FDA has no way of knowing how widespread the problems are unless patients who experience problems file a MedWatch report.
LASIK surgeons routinely downplay common complications of LASIK, such as night vision disturbances and dry eyes. However, the FDA's LASIK website cleary states that problems such as "halos, glare, night vision problems and dry eye from LASIK should be reported to FDA". Source
Submit your comments to the FDA public docket on LASIK
As part of its current investigation of reports of widespread problems related to use of LASIK devices, the FDA opened a docket to receive public comment. Let the FDA know how LASIK negatively affected your vision and quality of life by submitting your comments to the docket:
Read LASIK injury reports filed with FDA
You can access the FDA Maude database of reports of LASIK complications.
Click on the link below, then type LZS for excimer lasers or HNO for microkeratomes in the product code field. For Intralase (Intra-LASIK, blade-free LASIK, all-laser LASIK) type "IntraLase" in the Brand Name field. Select a date range to customize your search. All other field may be left blank.
File a complaint with the FTC for false advertising of LASIK
The responsibility for enforcement of federal laws regulating LASIK advertising is shared by the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA).
In October 2008 the FTC published updated guidance for marketing of LASIK surgery (www.ftc.gov/bcp/guides/eyecare2.shtm). The guidance states, “The FTC enforces Section 5 of the Federal Trade Commission Act (FTC Act), which prohibits deceptive or unfair practices in or affecting commerce, and Section 12 of the FTC Act, which prohibits the dissemination of any false advertisement to induce the purchase of any food, drug, device, or service [such as LASIK surgery].”
To file a complaint for deceptive or misleading LASIK ads contact the FTC's Division of Advertising Practices, Bureau of Consumer Protection or use the online complaint form.
File a complaint with the FDA for false advertising of LASIK
In May 2009 the FDA sent a reminder letter to eye care professionals regarding LASIK advertising. The letter states, “A restricted medical device [such as excimer laser] is misbranded under the Federal, Food, Drug, and Cosmetic Act (Act) if its advertising is false or misleading (21 U.S.C. 352(q)). In determining whether the advertisement is misleading, the FDA takes into account not only representations made or suggested by statement, word, or design, but also the extent to which the advertisement fails to reveal facts material in the light of such representations, or material with respect to consequences which may result from the use of the device to which the advertisement relates under the conditions of use prescribed in the advertisement (21 U.S.C. 321(n)).”...
"If you become aware of an advertisement for any of these restricted devices that may be in violation of the Act, please forward it to FDA’s Center for Devices and Radiological Health (CDRH), Office of Compliance at..."
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
9200 Corporate Blvd.
Rockville, MD 20850