Bausch + Lomb BL5115-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10757770058874), received between Oct 10, 2018 and Feb 21, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED BY THE USER FACILITY THAT A BURN OCCURRED DURING A CATARACT CASE. POSSIBLE CAUSES MAY HAVE BEEN THAT THE TUBING WAS HOOKED UP INCORRECTLY. SURGEON COMPLAINED OF AN UNSTABLE CHAMBER, AND LACK OF INFUSION DURING THE SCULPT MODE OF THE CASE. CORNEAL BURN WAS PRESENT, AND THE WOUND WAS SUTURED TO CLOSE. THE PATIENT HAS RECOVERED.

  Patient problems: Eye Burn

  MAUDE report 21434759 ↗
• InjuryMar 8, 2022Obstruction of Flow; Obstruction of Flow

  A USER FACILITY REPORTS AN IRIS BURN DUE TO AN IRRIGATION ISSUE THAT OCCURRED WHILE EXPERIENCING A TUBING MALFUNCTION. NO ADDITIONAL ANESTHESIA OR MEDICATION WAS NECESSARY, BUT THERE WAS SLIGHT INFLAMMATION AND THE SURGEON PLACED A STITCH AND PATCHED THE EYE UNTIL THE NEXT DAY. THE PATIENT IS OKAY. POST OP VISION WAS 20/40.

  Patient problems: Eye Burn

  MAUDE report 13685873 ↗
• MalfunctionMay 3, 2021Particulates; Particulates

  THE USER FACILITY REPORTED THAT DURING CATARACT SURGERY THE DOCTOR DISCOVERED WHAT LOOKS LIKE FIBERS IN THE PATIENT¿S EYE. THIS WAS FOLLOWING THE IMPLANTATION OF THE IOL. THE FOREIGN MATERIAL WAS REMOVED WITH THE IRRIGATION/ASPIRATION HANDPIECE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT, AND NO SIGNIFICANT DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761194 ↗
• InjuryApr 21, 2021Inability to Irrigate; Inability to Irrigate

  THE USER FACILITY REPORTED THERE WAS A LOSS OF IRRIGATION AND THE CHAMBER COLLAPSED DURING SURGERY RESULTING IN A RUPTURED CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, THERE HAS BEEN NO RESPONSE TO DATE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11699898 ↗
• MalfunctionOct 10, 2018Partial Blockage; Partial Blockage

  THE SURGEON WAS PERFORMING CATARACT SURGERY WHEN THE TUBING LINE CLOGGED PREVENTING THE ASPIRATION OF THE VISCOELASTIC. THEY OPENED A SECOND PACK TO FINISH THE CASE WITH NO IMPACT TO THE PATIENT. THE DOCTOR REPORTED, PROLONGED OPERATIVE TIME TO CHANGE PHACO PACK, AND POSSIBLY HIGHER IOP THAN WOULD HAVE BEEN OTHERWISE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953455 ↗