Bausch + Lomb BL5612Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00757770057689), received between Dec 14, 2016 and Apr 1, 2025 — 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 16, 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 1, 2025Failure to Cut; Failure to Cut

  THE USER FACILITY IN FRANCE REPORTED DURING AN OPERATION ON A PATIENT WITH A CATARACT, THE VITRECTOMY CUTTER STOPPED CUTTING BUT ASPIRATION CONTINUED. ANOTHER DEVICE WAS REQUIRED TO BE OPENED WITH A DELAY IN COMPLETING THE SURGERY. THE DELAY TIME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740252 ↗
• MalfunctionApr 17, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN CYPRUS REPORTED THE VITRECTOMY CUTTER WAS NOT WORKING. ONLY ASPIRATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753186 ↗
• MalfunctionOct 10, 2017Failure to Cut; Failure to Cut

  THE USER FACILITY REPORTED THE VITRECTOMY CUTER WOULD NOT CUT. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6935917 ↗
• MalfunctionApr 4, 2017Failure to Cut; Failure to Cut

  POOR CUTTING OF VITRECTOMY CUTTER. THE ASPIRATION DID NOT FAIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6456629 ↗
• MalfunctionJan 6, 2017Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THE INNER NEEDLE SOMETIMES GETS STUCK IN THE OPEN POSITION SO THE CUTTER DID NOT CUT. IT WAS REPLACED WITH ANOTHER CUTTER. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6229134 ↗
• MalfunctionDec 14, 2016Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(4) REPORTED THE CUTTER WAS NOT CUTTING WELL. NURSE CHANGED CUTTER AND WITH NO ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6173655 ↗