Bausch + Lomb SE5625BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10757770059734), received between May 15, 2023 and Apr 29, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (6 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Failure to Cut

  THE USER FACILITY IN ITALY REPORTED THAT THE VITRECTOMY CUTTER DIDN'T CUT AND ASPIRATION CONTINUED. THE CUTTER WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034094 ↗
• MalfunctionNov 15, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THE CUTTER WAS NOT CUTTING EFFICIENTLY FROM THE BEGINNING OF SURGERY. THE ASPIRATION WAS STILL WORKING ACCORDING TO THE SURGEON. ONCE THE CUTTER WAS CHANGED, EVERYTHING WAS FINE. THERE WAS NO PATIENT IMPACT NOR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142123 ↗
• MalfunctionAug 2, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN JAPAN REPORTED A VITRECTOMY CUTTER DID NOT MOVE. IT IS UNKNOWN IF THE ASPIRATION FUNCTION WORKED OR NOT. THE CUTTER WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444603 ↗
• MalfunctionJun 23, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED A FAULTY CUTTER DURING PROCEDURE. ADDITIONAL INFORMATION CONFIRMED THE CUTTER CONTINUED TO ASPIRATE WHILE THE FAULT OCCURRED. THERE WAS NO MEDICAL INTERVENTION REQUIRED, NO IMPACT OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17194267 ↗
• MalfunctionMay 15, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN THE UNITED KINGDOM STATED THAT DURING SURGERY THE VITRECTOMY CUTTER STOPPED, AND ASPIRATION CONTINUED. THERE WAS A DELAY IN SURGERY OF ABOUT 0-15 MINUTES. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT INJURY. THE PATIENT'S CURRENT STATUS IS REPORTED AS STABLE. THIS REPORT IS FOR THE SECOND CUTTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936548 ↗
• MalfunctionMay 15, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN THE UNITED KINGDOM STATED THAT DURING SURGERY THE VITRECTOMY CUTTER STOPPED, AND ASPIRATION CONTINUED. THERE WAS A DELAY IN SURGERY OF ABOUT 0-15 MINUTES. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT INJURY. THE PATIENT'S CURRENT STATUS IS REPORTED AS STABLE. THIS REPORT IS FOR THE FIRST CUTTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936256 ↗