TECNIS IOL DIU225 (REF DIU225U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474747173), received between Mar 13, 2023 and Jan 30, 2026 — classified as 3 injuries, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE-PIECE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO NEGATIVE DYSPHOTOPSIA. AFTER IMPLANTATION, THE PATIENT EXPERIENCED SYMPTOMS THAT WERE DESCRIBED AS SHADOWS AND FLASHES FROM THE LEFT EYE RADIATING TO THE RIGHT EYE. THE SYMPTOMS PERSISTED FOR APPROXIMATELY THREE MONTHS. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH A NON¿JOHNSON & JOHNSON IOL WITH A 22.0-DIOPTER POWER. NO UNPLANNED SURGICAL INTERVENTIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, WERE REQUIRED. NO DELAY IN THE PROCEDURE. IT IS UNKNOWN IF ANY MEDICATION WAS PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE. DIRECTIONS FOR USE WAS FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 24227810 ↗
• InjuryDec 23, 2025Unstable; Unstable

  IT WAS REPORTED THAT A CASE OF MYOPIC SURPRISE OCCURRED AFTER CATARACT SURGERY IN A PATIENT WITH A HISTORY OF LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK). AFTER DEVICE IMPLANTATION, THE PATIENT EXPERIENCED PERSISTENT BLURRY DISTANCE VISION, WITH POST-OPERATIVE REFRACTION SETTLING AT APPROXIMATELY -1.50, WHICH SIGNIFICANTLY IMPACTED PATIENT'S ABILITY TO SEE WELL. PRE-OPERATIVE: REFRACTION +1.00 +1.00 X 10; BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA): 20/30. POST-OPERATIVE: REFRACTION -1.50 +0.50 X 165; BSCVA 20/70. INTENDED TARGET: PLANO SPHERE; INTENDED AXIS 180; ACTUAL POST-OPERATIVE AXIS 165 THE PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF THE UNEXPECTED REFRACTIVE OUTCOME; THE DEVICE WAS NOT REPLACED DURING THAT PROCEDURE. A REPLACEMENT WAS SCHEDULED FOR (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23885598 ↗
• MalfunctionApr 15, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) HAD A SCRATCH. AFTER THE SURGEON INSERTED AND POSITIONED THE LENS THEY NOTICED IN THE MIDDLE OF THE LENS WAS A SCRATCH. THE DOCTOR CUT THE LENS OUT AND REPLACED IT WITH ANOTHER ONE OF THE SAME MODEL. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106979 ↗
• MalfunctionMar 5, 2024Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) HAPTIC STARTED TO SHEAR WHILE BEING INSERTED. THE LENS WAS PARTIALLY INSERTED. IT IS UNKNOWN IF ANY RESISTANCE WAS FELT WHEN ADVANCING THE LENS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS (SAME MODEL AND DIOPTER). IT IS UNKNOWN IF THE ISSUE WAS RELATED TO USE ERROR. THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE ARE NO PLANNED INTERVENTIONS. THE PATIENT OUTCOME WAS SATISFACTORY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838179 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) DID NOT GIVE ENOUGH NEAR VISION WITHOUT GLASSES DESPITE TARGET -1-25. PROBLEM OCCURRED AT ALL TIMES POST-IMPLANT. VISUAL ACUITY (VA) PRE-OPERATIVE (OP): 20/20 GLARE TO 20/40, POST-OP VA: 20/20. THE PATIENT NEEDED LENS EXCHANGE TO A MULTIFOCAL LENS. THERE WAS INCISION ENLARGEMENT, BUT NO VITRECTOMY, NO SUTURES. STANDARD POST-OP MEDS WERE GIVEN. REPORTEDLY, THE PATIENT HAD CATARACT SURGERY ON THE RIGHT EYE (OD). THE DOCTOR DID THE SURGERY WITH AN EYHANCE TORIC. AT PATIENT'S 1 WEEK APPOINTMENT, IT IS NOTED ¿PATIENT NOT HAPPY WITH HER VISION. SHE SAYS HER VISION IS VERY BLURRY DISTANCE AND NEAR OD. OS (LEFT EYE) IS STILL BLURRY. PATIENT WANTS TO WAIT UNTIL OD IS BETTER BEFORE PROCEEDING WITH OS SURGERY.¿ PATIENT HAS HAD NUMEROUS VISITS AND HAS NOT BEEN HAPPY WITH HER VISION. THE PATIENT CAME BACK AND SAW THE DOCTOR AND THEY DISCUSSED DOING AN IOL EXCHANGE. EXPLANT WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PRODUCT IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16530288 ↗