Bausch + Lomb BL5323WVRecalls & reported problems
Bausch & Lomb Incorporated · TSV 23ga Combined Vitrectomy Pack with Valves and Wide Field Illuminator · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00757770058563), received between Aug 2, 2017 and Jul 14, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut6
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2025Failure to Cut; Failure to Cut
A USER FACILITY IN CHINA REPORTED THAT DURING PROCEDURE, THE VITRECTOMY CUTTER WAS NOT CUTTING, BUT ASPIRATION CONTINUED. THERE WAS PATIENT CONTACT BUT NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22495889 ↗MalfunctionNov 8, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER DID NOT CUT, BUT STILL ASPIRATED DURING SURGERY. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639477 ↗MalfunctionMay 8, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER DID NOT CUT DURING THE SURGERY; HOWEVER, ASPIRATION CONTINUED. THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19271022 ↗MalfunctionMay 8, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER DID NOT CUT DURING THE SURGERY; HOWEVER, ASPIRATION CONTINUED. THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19270973 ↗MalfunctionMay 8, 2024Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER DID NOT CUT DURING THE SURGERY; HOWEVER, ASPIRATION CONTINUED. THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19270871 ↗MalfunctionAug 2, 2017Failure to Cut; Failure to Cut
THE CUTTER STOPS CUTTING AFTER 10 MINUTES, A NEW CUTTER IS REQUIRED TO FINISH THE SURGERY. NO PATIENT IMPACT OR INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6759603 ↗
Other Instrument, Vitreous Aspiration And Cutting, Ac-Powered devices
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- Centurion, OZil 8065751761Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered475 reports
- UNITY 00380650002969Alcon Laboratories, Inc. · Instrument, Vitreous Aspiration And Cutting, Ac-Powered271 reports
- Ozil 8065750469Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered261 reports
- Infiniti 8065752160Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered54 reports
- Bausch + Lomb SE5523WVBausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall4 reports
- Bausch + Lomb SE5525WVBausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.