TECNIS IOL DIU225 (REF DIU225U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474747104), received between Jun 14, 2021 and Aug 25, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE TORIC PRELOADED INTRAOCULAR LENS WAS OBSERVED TO BE DETACHED UNDER THE MICROSCOPE AFTER IT WAS INSERTED AND WAS SUBSEQUENTLY REMOVED. IT WAS BELIEVED TO BE LEAD HAPTIC. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. PATIENT IS DOING FINE POST-PROCEDURE. THROUGH FOLLOW UP, IT WAS LEARNT THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP J&J LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891815 ↗
• MalfunctionJan 21, 2025Break; Mechanical Jam; Break; Mechanical Jam

  THE PRE-LOADED DIU225 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO BE DIFFICULT TO DEPLOY AND CAME OUT OF THE DEVICE DAMAGED, CRUMBLED UP. THE IOL WAS ALSO STUCK IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT WITH THE IOL AND THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED USING A BACK-UP LENS THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS FINE. PROVISC WAS USED AT ROOM TEMPERATURE AND THERE WAS NO DELAY BETWEEN PREP AND HAND-OFF TO THE DOCTOR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21203026 ↗
• MalfunctionSep 1, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE TECNIS EYHANCE TORIC SIMPLICITY INTRAOCULAR LENS TRAILING HAPTIC WAS TRAPPED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673299 ↗
• MalfunctionNov 15, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAS FOREIGN MATERIAL ON IT. THERE WAS NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814119 ↗
• MalfunctionJun 14, 2021Break; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Break; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A DEPLOYING ISSUE THAT THE TRAILING HAPTIC WAS STICKING OUT OF WOUND AFTER IT WAS INSERTED INTO PATIENT'S EYE. THE TRAILING HAPTIC WOULD NOT TUCK IN AND THE SURGEON THOUGHT THERE WAS A BARB IN THE CARTRIDGE THAT WOULD HAVE IMPEDED IT TUCKING IN. THE SURGEON USED A SECOND INSTRUMENT TO DIAL THE LENS INTO THE BAG AND IT REMAINS IMPLANTED. THE DOCTOR ASKED IF THERE WAS A BARB IN THE CARTRIDGE THAT COULD HAVE IMPEDED IT TUCKING IN. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995500 ↗