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Bausch + Lomb BL5523WRecalls & reported problems

Bausch & Lomb Incorporated · TSV 23ga Combined Vitrectomy Pack with AFI and Wide Field Illuminator · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00757770058174), received between Feb 9, 2018 and Apr 16, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Device problems

  • Break1
  • Failure to Cut1

Patient problems

  • Eye Injury1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 16, 2019Break; Break

    THE USER FACILITY IN MAURITIUS REPORTED ONE OF THE TROCAR BROKE IN THE PATIENT'S EYE AT THE END OF THE VITRECTOMY PROCEDURE. THE INCISION WAS ENLARGED TO REMOVE THE CANNULA. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PATIENT IS STABLE.

    Patient problems: Eye Injury

    MAUDE report 8518899 ↗
  • MalfunctionFeb 9, 2018Failure to Cut; Failure to Cut

    THE VITRECTOR STOPPED WORKING DURING PHACO-VITRECTOMY SURGERY. ANOTHER VITRECTOR WAS USED TO COMPLETE THE SURGERY. THERE WAS NO INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7258924 ↗

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All Instrument, Vitreous Aspiration And Cutting, Ac-Powered devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.