Bausch + Lomb BL5223WVRecalls & reported problems
Bausch & Lomb Incorporated · TSV 23ga Posterior Vitrectomy Pack with Valves and Wide Field Illuminator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00757770058587), received between Nov 21, 2024 and Mar 10, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (8 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.
Reports received per month
Most reported problems
Device problems
- Failure to Cut8
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Failure to Cut
THE USER FACILITY IN CHINA REPORTED THAT DURING SURGERY THE VITRECTOMY CUTTER COULD NOT CUT. ASPIRATION CONTINUED AFTER THE CUTTER STOPPED. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561252 ↗MalfunctionFeb 16, 2026Failure to Cut
A USER FACILITY IN CHINA REPORTED THAT THE VITRECTOMY CUTTER STOPPED WORKING AND ASPIRATION CONTINUED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345489 ↗MalfunctionSep 19, 2025Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED ASPIRATION CONTINUED WHEN THE VITRECTOMY CUTTER STOPPED CUTTING DURING THE OPERATION. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097336 ↗MalfunctionSep 19, 2025Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED ASPIRATION CONTINUED WHEN THE VITRECTOMY CUTTER STOPPED CUTTING DURING THE OPERATION. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097328 ↗MalfunctionAug 18, 2025Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER COULD NOT CUT, BUT CONTINUED TO ASPIRATION DURING THE OPERATION. THERE WAS NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22828313 ↗MalfunctionJul 17, 2025Failure to Cut; Failure to Cut
THE USER FACILITY IN CHINA REPORTED THE VITRECTOMY CUTTER DID NOT CUT WHEN THE DOCTOR BEGAN TO PERFORM THE OPERATION. ASPIRATION CONTINUED WHILE THE CUTTER WAS NOT WORKING. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530723 ↗MalfunctionJan 18, 2025Failure to Cut; Failure to Cut
A USER FACILITY IN CHINA REPORTS THAT THE VITRECTOMY CUTTER WAS NOT CUTTING AND CONTINUED TO ASPIRATE. THE PROGRESS OF THE OPERATION WAS NOT AFFECTED. THE DOCTOR UPDATED THE PACK AND CONTINUED TO COMPLETE THE OPERATION. NO PATIENT IMPACT/INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21186466 ↗MalfunctionNov 21, 2024Failure to Cut; Failure to Cut
THE VITRECTOMY CUTTER CANNOT CUT, ASPIRATION CONTINUED WHEN THE CUTTER STOPPED. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20744577 ↗
Other Instrument, Vitreous Aspiration And Cutting, Ac-Powered devices
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- CONSTELLATION 8065753041Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered503 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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