TECNIS IOL DIU225 (REF DIU225U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474747203), received between Nov 17, 2023 and Sep 3, 2025 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL TECNIS EYHANCE TORIC INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED, THEN REMOVED AND REPLACED DURING THE SAME PROCEDURE ON (B)(6) 2025, DUE TO A SHEARED-OFF HAPTIC. NO OTHER MEDICAL INTERVENTIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957425 ↗
• MalfunctionApr 2, 2025Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) GOT STUCK IN THE CARTRIDGE DURING IMPLANTING THE LENS INTO THE PATIENT'S RIGHT EYE. IT WAS BEING HELD IN BY THE ROD. AFTER TRYING TO RETRACT AND ADVANCE SEVERAL TIMES, THE HAPTIC BROKE OFF. THE ISSUE WAS NOTICED DURING IMPLANTATION/APPLICATION. THE PART OF THE LENS IN THE EYE HAD TO BE CUT OFF AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER IN THE SAME PROCEDURE. THERE WERE NO COMPLICATIONS. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS ENOUGH OVD AS USUAL. SINCE TRAILING HAPTIC GOT STUCK IN CARTRIDGE WHILE THE RESTO OF THE IOL WAS NOT INSIDE THE EYE ON AC. THE ON AND OFF EFFORT TO TRY TO LIBERATE THE HAPTIC ENDED WITH THE BROKE THE TRAILING HAPTIC AT THE OPTIC JUNCTION. THERE WAS POST OP CORNEAL EDEMA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Corneal Edema

  MAUDE report 21756332 ↗
• InjurySep 6, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED AFTER IMPLANTATION THE PRE-LOADED DIU225 MODEL INTRAOCULAR LENS (IOL) WAS PUSHED FROM EYE DUE TO HIGH INCREASED INTRAOCULAR PRESSURE (IOP). THE IOL WAS REMOVED AND REPLACED WITH A DIU225 23.5 DIOPTER IOL DURING THE SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO PROCEDURAL DELAYS, AND NO MEDICAL ATTENTION WAS REQUIRED HOWEVER, AN UNPLANNED VITRECTOMY WAS PERFORMED. IT IS UNKNOWN IF MEDICATION WAS PRESCRIBED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED. IT WAS INDICATED THE IOL ITSELF WAS DISCARDED HOWEVER, THE INJECTOR IS AVAILABLE FOR RETURN. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 20163579 ↗
• MalfunctionNov 17, 2023Contamination; Material Opacification; Contamination; Material Opacification

  IT WAS REPORTED BY THE DOCTOR THAT HE IMPLANTED A TECNIS EYHANCE TORIC SIMPLICITY INTRAOCULAR LENS (IOL). ONCE THE LENS WAS IN THE EYE, HE NOTICED WHAT HE CALLED A SMALL PLAQUE ON THE OPTIC, (WHITE SPOT). HE WAS NOT SURE WHAT IT IS. THE LENS WAS LEFT IN THE EYE. HE FELT THAT IT WAS OUTSIDE OF THE PATIENT'S FIELD OF VISION. HE HAS A POST-OP VISIT ON NEXT DAY. ADDITIONAL INFORMATION RECEIVED STATED THAT THE DEFECT MUST HAVE BEEN THAT EMULSION ON THE LENS, BECAUSE IT¿S COMPLETELY GONE ON NEXT DAY DURING POST-OP EXAMINATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161914 ↗