Bausch + Lomb BLV3220000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00757770058402), received between Jul 6, 2017 and Apr 4, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Particulates” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Particulates; Particulates

  THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774934 ↗
• MalfunctionApr 3, 2025Particulates; Particulates

  THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767358 ↗
• MalfunctionApr 3, 2025Particulates; Particulates

  THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766860 ↗
• MalfunctionApr 3, 2025Particulates; Particulates

  THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766052 ↗
• MalfunctionApr 3, 2025Particulates; Particulates

  THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764566 ↗
• MalfunctionApr 2, 2025Particulates; Particulates

  THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755518 ↗
• MalfunctionDec 20, 2023Particulates; Particulates

  THE USER FACILITY REPORTS THAT THE PHACO SLEEVE HAS THREE HOLES IN IT AND ONE OF THE HOLES WAS NOT PUNCHED AND A PART OF THE GREEN SLEEVE GOT INTO THE ANTERIOR CHAMBER. THE DOCTOR WAS ABLE TO ASPIRATE IT OUT. THIS HAPPENED TWICE ON TWO SEPARATE PATIENTS ON THE SAME DAY. THE PRODUCTS WERE DISPOSED OF. THERE WAS NO MEDICAL INTERVENTION/TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365230 ↗
• MalfunctionDec 20, 2023Particulates; Particulates

  THE USER FACILITY REPORTS THAT THE PHACO SLEEVE HAS THREE HOLES IN IT AND ONE OF THE HOLES WAS NOT PUNCHED AND A PART OF THE GREEN SLEEVE AND GOT INTO THE ANTERIOR CHAMBER. THE DOCTOR WAS ABLE TO ASPIRATE IT OUT. THIS HAPPENED TWICE ON TWO SEPARATE PATIENTS ON THE SAME DAY. THE PRODUCTS WERE DISPOSED OF. THERE WAS NO MEDICAL INTERVENTION/TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365213 ↗
• MalfunctionJun 25, 2018Particulates; Particulates

  THE USER FACILITY REPORTED AS THE DOCTOR WAS PERFORMING PHACOEMULSIFICATION WHEN A BACK PARTICLE FELL INTO THE PATIENTS EYE. THE SURGEON WAS ABLE TO REMOVE THE PARTICLE, AND COMPLETE THE SURGERY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7635467 ↗
• MalfunctionJul 6, 2017Particulates; Particulates

  THE USER FACILITY REPORTED A PIECE OF PLASTIC CAME OUT OF THE SLEEVE DURING THE PROCEDURE. THE DOCTOR WAS UNSURE IF IT IS COMING FROM THE SLEEVE. HE USED A UTRATA FORCEPS TO REMOVE THE FOREIGN MATTER FROM THE EYE. NO ISSUE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6689705 ↗