Roles and Responsibilities–
In the United States, the Food and Drug Administration (FDA) regulates the sale of medical devices such as lasers used for LASIK. Before a laser can legally be marketed and sold, the manufacturer must conduct FDA-supervised clinical trials and submit the results of these clinical trials to the FDA. To gain FDA approval, clinical trials must demonstrate that the laser is reasonably safe and effective for a specific use.
The FDA defines certain requirements for the sale and use of lasers for LASIK in its approval letter to the manufacturer. Among these requirements is a “Patient Information Booklet”, which should be provided by the surgeon to all prospective patients prior to undergoing LASIK. The Patient Information Booklet (PIB), also known as “labeling”, is the device equivalent to the package insert that is provided with a prescription drug. The booklet provides information about clinical trial outcomes, and includes important safety warnings. The FDA approval letter to the laser manufacturer also reinforces the FDA’s requirement to report serious problems and adverse events after LASIK to the FDA through its MedWatch device monitoring program.
Your surgeon may not be willing to acknowledge that your problem is serious enough to qualify as an adverse event, however the FDA’s definition of an adverse event is “any problem that has a negative effect on your quality of life”. This definition includes chronic dry eyes and night vision difficulty:
“We encourage as much information as possible here, because FDA does look at every voluntary report that comes in. If it’s a decrease in vision, if it’s a halo, if it’s a starburst, if it’s a problem with night vision, these types of things would be considered adverse events to FDA, and we would want those reported because it has affected your vision,” said Mary Weick-Brady of the FDA’s Center for Devices and Radiological Health during an interview with National Public Radio.
How to report a problem
If you have suffered a serious problem due to LASIK, we encourage you to report your experience by filing a MedWatch report with the FDA.