TECNIS IOL DIU225 (REF DIU225U160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474747050), received between Jun 22, 2021 and Aug 31, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2023Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS FAULTY INSERTER IN A PRELOADED PRODUCT, BACK HAPTIC WAS SEVERED FROM THE LENS. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE. MICROSURGICAL TECHNOLOGY (MST) SET USED FOR REMOVAL OF THE LENS. THE LENS WAS REPLACED WITH THE BACK-UP LENS SAME MODEL, SAME DIOPTER POWER SIZE LENS. THERE WAS NO PATIENT POST-OP INJURY. THE SUSPECT PRODUCT IS NOT BEING RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666805 ↗
• MalfunctionDec 8, 2022Crack; Crack

  IT WAS REPORTED THAT WHEN INSERTING AN INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE, THE LENS DID NOT DEPLOY BECAUSE THE DEVICE TIP WAS BENT. THE TIP POSSIBLY TOUCHED THE PATIENT. REPORTEDLY, THIS IS NOT A STUCK IN CARTRIDGE ISSUE. THE ISSUE IS RELATED TO THE BENT TIP. IT CAME OUT OF THE PACKAGE THAT WAY. THE ISSUE IS NOT RELATED TO USE ERROR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP IOL. THERE WERE NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15945268 ↗
• MalfunctionJun 22, 2021Difficult to Fold, Unfold or Collapse; Difficult to Insert; Difficult to Fold, Unfold or Collapse; Difficult to Insert

  DURING SURGERY THE LEADING HAPTIC OF THE INTRAOCULAR LENS (IOL) WOULD NOT RELEASE FROM THE OPTIC; ONCE IT DID AFTER MANY MINUTES THE LENS DID NOT SIT WHERE THE SURGEON WANTED IT. DOCTOR ENDED UP CUTTING THE LENS OUT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12047024 ↗