Advocacy
MedWatch, and 177 complaints with no file
Anyone can file a MedWatch report. That is the public door. What happens inside a firm, before anyone uses that door, is visible only when FDA writes it down.
The BlephEx warning letter of June 3, 2026, is that kind of file. FDA says the complaint-handling procedure was “inadequate and not fully implemented” for “one hundred and seventy-seven plus (177+) complaints” on the eyelid-cleaning sponge. The vice president of operations, the letter says, “confirmed that no detailed complaint records existed for each of the 177+ complaints.” Examples in the letter include handpieces that “blew up” or “began smoking,” marked “not evaluated for reportability.” FDA’s line after that: the firm “failed to investigate serious device malfunctions, and failed to report potentially life-threatening events to FDA in a timely manner.” The letter calls it a repeat of a 2019 Form 483.
That is what an advocate can document from the open record: a count, a missing file, and the agency’s words. It is not a list of patients. It is not a clinic inspection. MedWatch is still the way a person puts a new event in front of the agency without waiting for the next inspection. The 177 is what it looks like when that step was not taken inside the firm, and FDA later said so in public.
fda.gov — MedWatch Voluntary Reporting Form
Notes on warning letter 725861
These notes describe a public reporting channel and quote one public manufacturer letter. They are not a finding about any clinic. Patient names do not appear in the letter.