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Bausch + Lomb BL5525WRecalls & reported problems

Bausch & Lomb Incorporated · TSV 25ga Combined Vitrectomy Pack with AFI and Wide Field Illuminator · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00757770058181), received between May 15, 2018 and Aug 7, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 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.

Most reported problems

Device problems

  • Failure to Cut3

Patient problems

  • No Consequences Or Impact To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 7, 2018Failure to Cut; Failure to Cut

    DURING A CATARACT PROCEDURE THE CUTTER HAD DIFFICULTY CUTTING. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7757058 ↗
  • MalfunctionAug 1, 2018Failure to Cut; Failure to Cut

    DURING A CATARACT SURGERY THE VITRECTOMY CUTTER STOPPED CUTTING YET CONTINUED ASPIRATING. THERE WAS NO PATIENT IMPACT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7739425 ↗
  • MalfunctionMay 15, 2018Failure to Cut; Failure to Cut

    THE VITRECTOMY CUTTER DOES NOT CUT YET CONTINUES TO ASPIRATE. THERE WAS NO PATIENT IMPACT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7516163 ↗

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.