TECNIS IOL DIU150 (REF DIU150U315)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474746770), received between Nov 9, 2021 and Jul 18, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2022Crack; Mechanical Problem; Crack; Mechanical Problem

  IT WAS REPORTED THAT THE INSERTER PLUNGER OF THE PRELOADED DEVICE WAS OFF TO THE SIDE OF OPTIC RATHER THAN BEING BEHIND THE HAPTIC OF THE INTRAOCULAR LENS AND SO DID NOT PUSH OUT CORRECTLY CAUSING THE TIP TO CRACK DUE TO THE EXTRA BULK OF PLUNGER TO THE SIDE OF OPTIC. AS THIS WAS THE SECOND LENS BEING USED ON THE PATIENT, THE DOCTOR TRIED A COUPLE TIMES TO MOVE THE PLUNGER BEHIND THE LENS AND AFTER A COUPLE TRY¿S WAS ABLE TO GET THE PLUNGER TO REALIGN WITH THE BACK OF THE LENS AND HE WAS ABLE TO INSERT THE LENS INTO THE RIGHT EYE. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE SURGEON WATCHED THE LOAD GOING TO SIDE UNDER THE MICROSCOPE AND NOT WHEN INSIDE PATIENT'S RIGHT EYE AND CONFIRMED THAT THE TIP OF THE CARTRIDGE WAS NOT CRACKED. IT WAS ASSESSED THAT THE INJECTOR DID NOT FUNCTION AS EXPECTED CAUSING THE LENS TO BUNDLE UP AND CRACKING THE CARTRIDGE. THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048673 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO A PATIENT'S RIGHT EYE, THE DOCTOR FOUND THE PATIENT'S ZONULES TO BE WEAK/LOOSE. THERE WAS A CAPSULE TEAR AFTER THE LENS WAS INSERTED AND VITREOUS LOSS WAS NOTED. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND A VITRECTOMY WAS PERFORMED. NO REPLACEMENT LENS WAS INSERTED (THE PATIENT IS APHAKIC). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; Vitreous Loss; Zonular Dehiscence

  MAUDE report 12783024 ↗