Bausch + Lomb INJ100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00757770505326), received between Mar 22, 2023 and Aug 19, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2025Failure to Eject; Failure to Eject

  THE HEALTH CARE FACILITY REPORTED DURING AN INTRAOCULAR LENS IOL IMPLANT PROCEDURE, THE LENS HOOKED IN THE INJECTOR. THE PROCEDURE TIME WAS PROLONGED BY APPROXIMATELY 20 MINUTES AND WAS COMPLETED WITH A DIFFERENT MODEL IOL, A CAPSULAR TENSION RING AND A SULCUS-SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837385 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT REPORT RELATES TO THE PATIENT¿S LEFT EYE. THE REPLACEMENT IOL WAS A PRELOADED LENS WITH THE SAME MODEL AND DIOPTER. THE PATIENT HAS NOT NOTICED A DECREASE IN THEIR VISION.

  Patient problems: Visual Disturbances

  MAUDE report 18191013 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEADING HAPTIC BROKE OFF WHEN INSERTING THE INTRAOCULAR LENS (IOL) INTO THE EYE. THE HAPTIC REMAINED IN THE INJECTOR CHAMBER. THE LENS WAS CUT AND THE INCISION WAS ENLARGED TO REMOVE THE LENS. ANOTHER LENS WITH THE SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245630 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE SURGEON DISCOVERED A BROKEN HAPTIC AFTER IMPLANTATION OF AN INTRAOCULAR LENS. THE LENS WAS REMOVED INTRAOPERATIVELY. A REPLACEMENT LENS OF THE SAME DIOPTER WAS IMPLANTED 1-WEEK POSTOP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240203 ↗
• InjuryMar 22, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT AN IOL WAS INTRODUCED INTO THE PATIENT'S EYE WITH THE LEADING HAPTIC STICKING OUT AND THE TRAILING HAPTIC STUCK IN THE INJECTOR. DURING INSERTION, THE TRAILING HAPTIC THEN BROKE. THE SURGEON DECIDED TO CUT THE IOL IN HALF AND REMOVE FROM THE EYE. THE INCISION WAS ENLARGED. AN IOL OF THE SAME MODEL AND DIOPTER WAS INSERTED SUCCESSFULLY. IN THE SURGEON'S OPINION, THE LIKELY CAUSE OF THE EVENT WAS INCORRECT LOADING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589388 ↗