Bausch + Lomb BL5523WVXRecalls & reported problems
Bausch & Lomb Incorporated · TSV 23ga Combined Vitrectomy Pack with Valves and AFI and Wide Field Illuminator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00757770059119), received between Jun 18, 2021 and Aug 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (2 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 Cut2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50500417 ↗MalfunctionJun 18, 2021Failure to Cut; Failure to Cut
THE USER FACILITY IN (B)(6) REPORTED THE CUTTER STOPPED WORKING SPONTANEOUSLY. WHEN THE CUTTER STOPPED CUTTING THE ASPIRATION CONTINUE SLOWLY. THERE WAS NO MEDICAL INTERVENTION REQUIRED, NO IMPACT OR INJURY TO THE PATIENT, NO NEED FOR SURGERY TO BE PROLONGED, AND NO ADDITIONAL ANESTHESIA WAS NEEDED. THE SURGERY WAS COMPLETED WITH THE REPLACEMENT OF A NEW PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12025617 ↗
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- 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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