Malosa Medical MMSU1172SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 35055186206001), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Material Disintegration; Material Disintegration

  A COMPLAINT WAS RECEIVED FOR PRODUCT MMSU1172S - LASIK FLAP SEPARATOR (SEIBEL), IN WHICH A SURGEON REPORTED OBSERVING FINE METALLIC PARTICLES BENEATH THE CORNEAL FLAP ON POSTOPERATIVE DAY ONE. THE PARTICLES WERE NOT REMOVED, AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED TO DATE. THE PHYSICIAN REQUESTED INSTRUMENTS FROM A DIFFERENT LOT, NOTING THAT SIMILAR ISSUES HAVE PREVIOUSLY OCCURRED WITH OLDER REUSABLE INSTRUMENTS. ACCORDING TO A CLINICAL EXPERT, THE PRESENCE OF INTERFACE DEBRIS (METAL OR PLASTIC PARTICLES), IF NOT REMOVED, POSES A POTENTIAL RISK OF DEVELOPING DIFFUSE LAMELLAR KERATITIS (DLK), ALSO KNOWN AS "SANDS OF THE SAHARA" SYNDROME AN INFLAMMATORY CONDITION THAT CAN RESULT IN SERIOUS INJURY, INCLUDING CORNEAL HAZE AND VISION LOSS. THE MALFUNCTION WAS IDENTIFIED POSTOPERATIVELY BUT DID NOT RESULT IN ANY ADVERSE HEALTH EFFECTS AND THE PHYSICIAN DECIDED THAT IT DOESN'T REQUIRE MEDICAL INTERVENTION. ALTHOUGH RECURRENCE DOES NOT GUARANTEE HARM, IT CARRIES THE POTENTIAL FOR SERIOUS INJURY, PARTICULARLY IF TOXIC, ALLERGIC, OR INFLAMMATORY RESPONSES ARE TRIGGERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541762 ↗