Bausch + Lomb BL5115-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770058867), received between Apr 9, 2021 and Dec 20, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Intermittent Communication Failure” (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

Recent adverse event reports

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

• InjuryDec 20, 2023Intermittent Communication Failure; Intermittent Communication Failure

  A USER FACILITY IN FRANCE REPORTED THAT THE INTERACTION BETWEEN THE HANDPIECE AND THE SLEEVE RESULTED IN THE INCISION BEING BURNT, SUTURES WERE REQUIRED. THE PATIENT RECOVERED WELL, WITH NO EFFECT ON VISUAL ACUITY.

  Patient problems: Eye Burn

  MAUDE report 18366668 ↗
• MalfunctionApr 9, 2021Particulates; Particulates

  THE USER FACILITY IN (B)(6) REPORTED THAT AT THE BEGINNING OF PHACOEMULSIFICATION, A SMALL WHITE PARTICLE CAME OUT OF THE PHACO NEEDLE, AND AIR BUBBLES COULD NOT BE STOPPED. THE PARTICLE WAS REMOVED FROM THE EYE AND THE PROCEDURE WAS PROLONGED BY 10 MINUTES. THE PATIENT NEEDED ADDITIONAL ANESTHESIA IN A TEARDROP SHAPE. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT IS FINE, WITH NO ABNORMALITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11644958 ↗