Bausch + Lomb BL5110Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20757770057010), received between Dec 21, 2016 and Oct 22, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Particulates” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Product Quality Problem; Product Quality Problem

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING CATARACT SURGERY BUBBLES OCCURRED AND OBSCURED THE SURGEONS VIEW. THIS CAUSED THE PHACO TIP TO TOUCH THE CAPSULE BAG AND RESULTED IN A RUPTURE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND SURGERY WAS INCREASED BY 15-30 MINUTES. NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23359928 ↗
• InjuryJul 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED BY A USER FACILITY IN TURKEY THAT DURING THE CASE, WATER LEAKED FROM THE CASSETTE CHAMBER OF THE DEVICE. THE CASE WAS PAUSED UNTIL THE PUMP WAS DRIED AND A NEW CASSETTE WAS INSTALLED. DUE TO THE DRYING TIME OF THE CASSETTE CHAMBER THE CASE WAS PROLONGED BY APPROXIMATELY ONE HOUR. SEDATION WAS GIVEN TO THE PATIENT. IN ADDITION, WHILE THE PATIENT WAS UNDER THE EFFECT OF LOCAL ANESTHESIA, THEY MOVED CAUSING AN EDEMA IN THE CORNEA. THE PATIENT IS NOW IN GOOD CONDITION.

  Patient problems: Corneal Edema

  MAUDE report 19709103 ↗
• MalfunctionNov 1, 2023Particulates; Particulates

  A USER FACILITY IN FRANCE REPORTED THAT THREE SMALL METAL WIRES CAME OUT OF THE ULTRASONIC HANDPIECE AND ENTERED THE EYE AS SOON AS THE INFUSION WAS ACTIVATED. THE FOREIGN MATERIAL WAS REMOVED WITH TROUTMAN FORCEPS.

  Patient problems: Insufficient Information

  MAUDE report 18048626 ↗
• MalfunctionNov 1, 2023Particulates; Particulates

  A USER FACILITY IN FRANCE REPORTED THAT THREE SMALL METAL WIRES CAME OUT OF THE ULTRASONIC HANDPIECE.

  Patient problems: Insufficient Information

  MAUDE report 18048509 ↗
• MalfunctionNov 1, 2023Particulates; Particulates

  A USER FACILITY IN FRANCE REPORTED THAT THREE SMALL METAL WIRES CAME OUT OF THE ULTRASONIC HANDPIECE.

  Patient problems: Insufficient Information

  MAUDE report 18048422 ↗
• MalfunctionApr 7, 2023Particulates; Particulates

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT THE SURGEON NOTICED A SMALL FOREIGN BODY FLUSH INTO ANTERIOR CHAMBER AT START OF PHACO. THE OBJECT WAS REMOVED. IT WAS DESCRIBED AS ¿WHITE PLASTIC¿, AND TRANSLUCENT MATERIAL. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702841 ↗
• MalfunctionMar 28, 2023Particulates; Particulates

  A USER FACILITY IN THE UNITED KINGDOM REPORTED A PIECE OF PLASTIC ENTERED THE EYE OUT OF THE PHACO TIP NEEDLE. THE PIECE OF PLASTIC WAS RETRIEVED FROM THE EYE AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628402 ↗
• InjuryMay 23, 2018Difficult to Insert; Difficult to Insert

  THE CUSTOMER REPORTED THAT A BLUE PARTICLE WAS OBSERVED IN THE EYE. THE PARTICLE WAS REMOVED FROM THE EYE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7538628 ↗
• MalfunctionDec 21, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  LIGHT BLUE RESIDUE FOUND INSIDE THE EYE OF THE PATIENT. IT WAS IMMEDIATELY REMOVED BY THE SURGEON. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7140305 ↗
• MalfunctionDec 19, 2017Difficult to Insert; Difficult to Insert

  THE SLEEVE LEFT ONE SMALL LIGHT BLUE PARTICLE IN THE PATIENT'S EYE. THE SURGEON WAS ABLE TO REMOVE IT IMMEDIATELY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7130567 ↗
• MalfunctionMay 8, 2017Difficult to Insert; Difficult to Insert

  THE SURGEON REPORTED THE SLEEVE DID NOT ENTER THE INCISION SMOOTHLY AND WAS DIFFICULT TO INSERT. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6552689 ↗
• MalfunctionMay 8, 2017Difficult to Insert; Difficult to Insert

  THE SLEEVE COLLAPSED DURING INSERTION AND WOULD NOT ENTER THE INCISION SMOOTHLY. ADDITIONAL FORCE WAS NEEDED TO INSERT THE SLEEVE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6552675 ↗
• MalfunctionApr 25, 2017Particulates; Particulates

  A REPORT RECEIVED FROM A USER FACILITY IN THE (B)(6) STATED THAT DURING A CATARACT PROCEDURE, A PARTICLE WAS SEEN COMING OUT OF THE IRRIGATION PORT AT THE BEGINNING OF A CASE. THERE WAS NO REPORT OF INJURY OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6519874 ↗
• MalfunctionDec 21, 2016Particulates; Particulates

  THE USER FACILITY REPORTS OBSERVING WHAT APPEARS TO BE GLITTER IN THE EYE WOUNDS OF SEVERAL PATIENTS. THE GLITTER HAS BEEN OBSERVED DURING POST-OP EXAMINATION WITH A SLIT LAMP OVER THE PAST SEVERAL MONTHS. THE USERS REPORTED NOTICING THE SLEEVES THAT COVER THE PHACO TIP AND I/A TIPS APPEAR TO HAVE GLITTER OR A SHIMMER ON THE SURFACE. TO DATE, THERE HAVE BEEN NO PATIENT COMPLICATIONS DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6195360 ↗