Bausch + Lomb BL5425WVRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00757770058648), received between Jan 25, 2017 and Jul 3, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Failure to Cut; Failure to Cut

  A USER FACILITY IN CHINA REPORTED THAT DURING AN OPERATION THE VITRECTOMY CUTTER DID NOT CUT WELL, AND CONTINUED TO ASPIRATE. THE CUTTER WAS REPLACED. THERE WAS PATIENT CONTACT, AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395744 ↗
• MalfunctionJun 30, 2025Failure to Cut; Failure to Cut

  THE USER FACILITY IN CHINA REPORTED DURING AN OPERATION, THE VITRECTOMY CUTTER WAS NOT SHARP ENOUGH TO CUT WELL. WHILE THE CUTTER WAS STOPPED TO BE REPLACED, ASPIRATION FUNCTION CONTINUED AT A SIGNIFICANTLY REDUCED RATE, WITH MANY BUBBLES IN THE SUCTION PIPE. THERE WAS CONTACT WITH THE PATIENT'S EYE, BUT NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360864 ↗
• MalfunctionMar 11, 2025Failure to Cut; Failure to Cut

  A USER FACILITY IN CHINA REPORTS THAT THE VITRECTOMY CUTTER IS NOT CUTTING WHILE STILL ASPIRATING DURING THE OPERATION. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577296 ↗
• MalfunctionJan 8, 2025Failure to Cut; Failure to Cut

  THE USER FACILITY IN CHINA REPORTED THAT THE VITRECTOMY CUTTER WAS NOT CUTTING YET WAS STILL ASPIRATING DURING SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21107350 ↗
• MalfunctionSep 25, 2024Failure to Cut; Failure to Cut

  THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER CAN NOT CUT WHILE STILL ASPIRATING. NO IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300036 ↗
• MalfunctionJan 10, 2024Failure to Cut; Failure to Cut

  THE USER FACILITY IN CHINA REPORTED A VITRECTOMY CUTTER WAS NOT CUTTING.

  Patient problems: Insufficient Information

  MAUDE report 18483568 ↗
• MalfunctionDec 13, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN CHINA REPORTS THAT THE VITRECTOMY CUTTER WAS NOT CUTTING. IT IS UNKNOWN IF ASPIRATION CONTINUED AND CUTTING STOPPED, OR IF THERE WAS ANY PATIENT IMPACT, AND WHAT THE OUTCOME IS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319936 ↗
• MalfunctionJun 8, 2018Particulates; Particulates

  THE DOCTOR REPORTED HEARING EXCESSIVE ¿CHIRPING¿ FROM THE VITRECTOR, AND OBSERVED WHAT APPEARED TO BE A WHITE METALLIC DUST COMING OUT OF THE VITRECTOR. THEY OPENED ANOTHER PACK. THE PARTICULATE WAS REMOVED AND SURGERY COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7582075 ↗
• MalfunctionSep 21, 2017Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED DURING SURGERY THE VITRECTOMY CUTTER DID NOT HAVE ADEQUATE CUTTING ACTION WHEN SET AT OR ABOVE 3500CPM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6883673 ↗
• InjuryJun 15, 2017Aspiration Issue; Aspiration Issue

  THE USER FACILITY REPORTED THE VITRECTOMY CUTTER WAS NOT ASPIRATING DURING SURGERY. THE SURGEON MOVED THE CUTTER CAUSING TRACTION ON THE RETINA RESULTING IN A RETINAL DETACHMENT.

  Patient problems: Retinal Injury

  MAUDE report 6642904 ↗
• MalfunctionJan 25, 2017Failure to Cut; Failure to Cut

  CUSTOMER IS HAVING ISSUES WITH THE CUTTER STOPPING DURING SURGERY. A REPLACEMENT CUTTER WAS USED TO COMPLETE THE PROCEDURE. THE DATE OF EVENT IS NOT AVAILABLE, AND NO PRODUCT WILL BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6277567 ↗