Synergetics 12.21PINRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841305102337), received between Aug 17, 2021 and Aug 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionAug 17, 2021Material Separation; Material Separation

  A USER FACILITY IN (B)(6) REPORTED THAT DURING CONTACT WITH A FOREIGN BODY, THE MAGNETIZED PART OF THE INSTRUMENT BECAME DETACHED FROM THE INSTRUMENT AND REMAINED IN CONTACT WITH THE FOREIGN BODY. THE INSTRUMENT WAS REMOVED FROM THE EYE WITHOUT ITS TIP, WHICH REMAINED IN THE INTRAOCULAR SPACE. THE DEFECTIVE TIP WAS THEN REMOVED FROM THE EYE. NO CLINICAL CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332810 ↗