Synergetics BL5625SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20841305109982), received between Jun 30, 2025 and Jun 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 30, 2025Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THAT DURING A VITRECTOR ANTERIOR CAPSULOTOMY, THE VITRECTOMY CUTTER WAS NOT CUTTING, AND IT SEEMED TO NOT BE WORKING CORRECTLY. THE ASPIRATION CONTINUED TO WORK. THE PHYSICIAN WAS NOT ABLE TO CAPTURE ANYTHING, INCLUDING APPARENTLY NORMAL LENS CAPSULE. THE CAPSULE HAD A DENSE CENTRAL PLAQUE WHICH THE SURGEON WASN'T ABLE TO CAPTURE OR CUT. AFTER CUTTING THE BAG WITH MST SCISSORS, THE SURGEON STILL WAS NOT ABLE TO CAPTURE ANY OF THE APPARENTLY NORMAL PERIPHERAL CAPSULE EITHER. THE SURGEON THEN SWITCHED TO A 23G VIT CUTTER AND REMOVED THE NUCLEUS WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358588 ↗