Bausch + Lomb BL5423WVRecalls & reported problems
Bausch & Lomb Incorporated · TSV 23ga Posterior Vitrectomy Pack with Valves and AFI and Wide Field Illuminator · Class 2
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00757770058556), received between Jan 25, 2017 and Aug 26, 2025 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (21 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut21
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient7
- Insufficient Information3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2025Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THAT DURING PROCEDURE THE VITRECTOMY CUTTER COULD NOT CUT WELL. THE ASPIRATION RATE WAS SIGNIFICANTLY REDUCED BUT CONTINUED WITH MANY BUBBLES IN THE SUCTION PIPE. THEY REPLACED THE CUTTER AND CONTINUED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22896304 ↗MalfunctionJul 11, 2025Failure to Cut; Failure to Cut
A USER FACILITY FROM CHINA REPORTED THAT DURING SURGERY THE VITRECTOMY CUTTER WAS NOT SHARP ENOUGH TO CUT AND ASPIRATION CONTINUED. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22481340 ↗MalfunctionJan 7, 2025Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED A VITRECTOMY CUTTER WAS NOT CUTTING BUT CONTINUED TO ASPIRATE DURING A PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 21095596 ↗MalfunctionNov 21, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING DURING SURGERY; HOWEVER, ASPIRATION CONTINUED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20746680 ↗MalfunctionNov 21, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING DURING SURGERY; HOWEVER, ASPIRATION CONTINUED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20744495 ↗MalfunctionAug 9, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING WHEN DURING SURGERY; HOWEVER, ASPIRATION CONTINUED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19948258 ↗MalfunctionMar 12, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER DIDN''T CUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18889361 ↗MalfunctionFeb 2, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED A VITRECTOMY CUTTER WAS NOT CUTTING.
Patient problems: Insufficient Information
MAUDE report 18630283 ↗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 18483588 ↗MalfunctionJan 2, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18425322 ↗MalfunctionMay 30, 2023Failure to Cut; Failure to Cut
THE MALFUNCTION OCCURRED DURING THE PROCESS OF CUTTING THE VITREOUS BODY. THE ASPIRATION CONTINUED AS NORMAL WHEN THE CUTTING STOPPED WORKING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17021882 ↗MalfunctionOct 20, 2021Failure to Cut; Failure to Cut
THE (B)(6) NATIONAL MEDICAL DEVICE ADVERSE EVENTS REPORTING SYSTEM REPORTS THAT THE HOSPITAL WAS PERFORMING VITRECTOMY WHERE THE DISPOSABLE PACK WAS USED. DURING SURGERY, THE DOCTOR FOUND THAT THE CUTTER DID NOT WORK. THE PRODUCT WAS STOPPED, REMOVED, AND IMMEDIATELY REPLACED WITH ANOTHER. VALID CONTACT INFORMATION WAS NOT PROVIDED MAKING FOLLOW-UP IMPOSSIBLE. IT COULD NOT BE DETERMINED IF ASPIRATION CONTINUED DURING THE TIME THE CUTTER STOPPED WORKING. IT WAS REPORTED THAT THERE WAS NO ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12666291 ↗MalfunctionJun 19, 2019Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED WHILE A PATIENT UNDERWENT SURGERY THE VITRECTOMY CUTTER WAS NOT WORKING NORMALLY. THE CUTTER WAS CHANGED IMMEDIATELY. THE SURGERY WAS COMPLETED WITH NO INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8711496 ↗MalfunctionApr 12, 2018Failure to Cut; Failure to Cut
THE CUTTER WOULD NOT CUT. THERE WAS PATIENT CONTACT BUT NO INJURY. THE DOCTOR OPENED A NEW CUTTER AND THE SURGERY WAS COMPLETED WITH NO ISSUES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7426567 ↗MalfunctionMar 8, 2018Failure to Cut; Failure to Cut
THE USER FACILITY REPORTED TWO OF THE VITRECTOMY CUTTERS DID NOT CUT. ADDITIONAL INFORMATION: THERE WAS ONLY 1 PATIENT INVOLVED AND THEY WERE ABLE TO GET THE THIRD PACK OPENED TO CUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7324347 ↗MalfunctionMar 8, 2018Failure to Cut; Failure to Cut
THE USER FACILITY REPORTED TWO OF THE VITRECTOMY CUTTERS DID NOT CUT. ADDITIONAL INFORMATION: THERE WAS ONLY 1 PATIENT INVOLVED, AND THEY WERE ABLE TO GET THE THIRD PACK OPENED TO CUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7324339 ↗MalfunctionMar 8, 2018Failure to Cut; Failure to Cut
THE USER FACILITY REPORTED TWO OF THE VITRECTOMY CUTTERS DID NOT CUT. ADDITIONAL INFORMATION: THERE WAS ONLY 1 PATIENT INVOLVED, AND THEY WERE ABLE TO GET THE THIRD PACK OPENED TO CUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7324334 ↗MalfunctionMar 7, 2017Failure to Cut; Failure to Cut
THE VITRECTOMY CUTTER IS NOT CUTTING. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6385398 ↗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 6277613 ↗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 6277556 ↗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 6277535 ↗
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- Bausch + Lomb SE5523WVBausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall4 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.