For more information, we developed some questions and answers on the Medical Device Reporting Regulation. This regulation specifies the reporting obligations of medical device manufacturers, importers, distributors, and user facilities. FDA has defined a device user facility as as hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility or outpatient treatment facility.
In order for us to effectively follow up on a report of LASIK-related problems with your eyes that affect your life, please be sure to include the following information under section E, "Suspect Medical Device," on the MedWatch form:
- Name of the device (i.e., specific name of the laser)
- Device manufacturer.