Bausch + Lomb BL5626Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770058898), received between Nov 8, 2024 and Nov 8, 2024 — classified as 1 injury.

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

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 8, 2018Terminated

   The back cap separates from the body of the vitrectomy cutter.

   Z-3265-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

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

• InjuryNov 8, 2024Crack; Crack

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING SURGERY THE DEVICE EXPLODED AND CAME APART. THE NOISE CAUSED THE PATIENT TO JUMP. SUTURES AND PAIN RELIEF WERE REQUIRED, NO ADDITIONAL SURGERIES WERE REQUIRED.

  Patient problems: Eye Pain

  MAUDE report 20639420 ↗