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Bausch + Lomb BL5420WRecalls & reported problems

Bausch & Lomb Incorporated · 20ga Posterior Vitrectomy Pack with AFI and Wide Field Illuminator · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00757770058136), received between Feb 17, 2017 and Feb 17, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (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

  • Failure to Cut1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 17, 2017Failure to Cut; Failure to Cut

    A REPORT RECEIVED FROM A HEALTHCARE PROFESSIONAL IN (B)(6) INDICATED THAT THE VIT CUTTER DID NOT CUT CORRECTLY DURING THE PROCEDURE. THERE WAS NO REPORT OF INJURY OR CONSEQUENCES TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6341247 ↗

Other Instrument, Vitreous Aspiration And Cutting, Ac-Powered devices

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.