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Bausch + Lomb BL5520WRecalls & reported problems

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

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00757770058167), received between Jul 11, 2018 and Jul 11, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Failure to Cut1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 11, 2018Failure to Cut; Failure to Cut

    USER FACILITY IN (B)(6) REPORTED THAT DURING CORE VITREOUS REMOVAL, THE SURGEON NOTICED THE CUTTER FAILED TO BE CUTTING THOUGH STILL ASPIRATING. CUTTER WAS REMOVED FROM THE EYE AND TESTED IN GALLIPOT AT 1000CPM AND AGAIN AT 5000CPM. HOWEVER SURGEON REPORTED THAT THE CUTTER WAS STILL NOT CUTTING. A NEW PACK WAS OPENED AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO EFFECT ON THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7679206 ↗

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Sources and updates

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