Bausch + Lomb BL5523WVRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00757770058549), received between Apr 4, 2017 and Aug 13, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Failure to Cut; Failure to Cut

  A USER FACILITY IN CHINA REPORTED THAT DURING THE OPERATION, THE VITRECTOMY CUTTER FAILED TO CUT WHILE CONTINUING TO ASPIRATE. THE DOCTOR FOUND "SKEW" OF THE VITRECTOMY CUTTER. NO PATIENT IMPACT/INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973454 ↗
• MalfunctionJun 17, 2024Failure to Cut; Failure to Cut

  THE USER FACILITY IN CHINA REPORTED THAT THE VITRECTOMY CUTTER DID NOT CUT DURING PROCEDURE. THE CUTTER CONTINUED TO ASPIRATE. THE SURGERY WAS PROLONGED FOR 5 MINUTES. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. THERE WAS NO PATIENT IMPACT REPORTED. THE PATIENT IS CURRENTLY IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19551236 ↗
• MalfunctionDec 21, 2023Failure to Cut; Failure to Cut

  ASPIRATION CONTINUED. THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371145 ↗
• MalfunctionJul 11, 2018Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(6) REPORTED THAT THE SURGEON NOTICED THAT THE CUTTER FAILED TO BE CUTTING THOUGH STILL ASPIRATING DURING CORE VITREOUS REMOVAL. CUTTER WAS REMOVED FROM THE EYE AND TESTED IN GALLIPOT AT 1000CPM AND AGAIN AT 5000CPM TO NO EFFECT. AS A RESULT, A NEW PACK WAS OPENED AND CUTTER WAS REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679143 ↗
• MalfunctionMar 16, 2018Failure to Cut; Failure to Cut

  THE DOCTOR AT THE USER FACILITY IN (B)(6) REPORTED THE CUTTER WAS UNABLE TO CUT AT CERTAIN ANGLES. THE NURSE OPENED A NEW PACK TO COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7345308 ↗
• MalfunctionSep 1, 2017Failure to Cut; Failure to Cut

  A REPORT FROM A FACILITY IN THE (B)(4) STATED THAT THE VITRECTOMY CUTTER WAS NOT CUTTING PROPERLY AND IT WAS CAUSING TRACTION. THE CUTTER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY INJURY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6837621 ↗
• MalfunctionAug 25, 2017Failure to Cut; Failure to Cut

  A REPORT RECEIVED FROM A USER FACILITY IN THE (B)(6) STATED THAT THE CUTTER STOPPED WORKING AFTER CUTTING THE VITREOUS. THE CUTTER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY INJURY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6820334 ↗
• MalfunctionAug 11, 2017Failure to Cut; Noise, Audible; Failure to Cut; Noise, Audible

  A REPORT FROM A USER FACILITY IN (B)(6) STATED THAT ACCORDING TO THE SURGEON THE CUTTER WAS MAKING A SOUND THAT WAS DIFFERENT FROM NORMAL AND ALSO APPEARED NOT TO BE WORKING CORRECTLY. A NEW CUTTER FROM A DIFFERENT PACK WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6789391 ↗
• MalfunctionApr 7, 2017Failure to Cut; Failure to Cut

  AT THE INSERTION OF THE VITRECTOMY CUTTER IT WOULD NOT CUT HOWEVER THE ASPIRATION CONTINUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6471583 ↗
• MalfunctionApr 4, 2017Failure to Cut; Failure to Cut

  AFTER INSERTING THE VITRECTOMY CUTTER IT DOES NOT CUT HOWEVER IT DOES ASPIRATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6456774 ↗