TECNIS IOL DIU225 (REF DIU225U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474747098), received between Nov 11, 2021 and Dec 29, 2025 — classified as 4 injuries, 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO THE PATIENT NOT BEING HAPPY. IT IS UNKNOWN IF ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND REPLACEMENT LENS IS UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 23918855 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER INDICATED ON THE FORM THAT NO FURTHER PATIENT INFORMATION WAS PROVIDED DUE TO DATA PRIVACY LEGISLATION. IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO AN UNSPECIFIED REASON POSSIBLY UNEXPECTED REFRACTION ALTHOUGH THE CUSTOMER WAS UNCERTAIN. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. AND THERE WAS NO UNPLANNED INCISION ENLARGEMENT, VITRECTOMY, SUTURES OR DELAY IN PROCEDURE. THE EXPLANTED IOL WAS REPLACED WITH THE SAME MODEL BUT A DIFFERENT DIOPTER 12.0. THE PATIENT OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 23764727 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT A DIVOT IN THE MIDDLE OF THE TORIC INTRAOCULAR LENS (IOL) WAS IDENTIFIED DURING THE PROCEDURE. THE LENS WAS FULLY INSERTED AND SUBSEQUENTLY REMOVED FROM THE PATIENT'S RIGHT EYE DURING THE SAME PROCEDURE. BOTH THE LENS AND THE CARTRIDGE CAME INTO CONTACT WITH THE PATIENT¿S EYE. THE PROCEDURE COMPLETED SUCCESSFULLY WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO CAPSULE TEAR, NO UNPLANNED VITRECTOMY, NO SUTURES AND NO MEDICATION OUTSIDE THE STANDARD OF CARE REQUIRED. IT IS UNKNOWN IF THERE WAS AN INCISION ENLARGEMENT. THE PATIENT OUTCOME IS UNKNOWN. THE ISSUE DID NOT IMPACT PATIENT'S ACTIVITIES OF DAILY LIFE. IT WAS CONFIRMED THAT THE DIRECTION FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325344 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN DURING INSERTION INTO THE EYE. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207544 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIU225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT WAS UNABLE TO TOLERATE MONOVISION AND HER DAILY ACTIVITIES WERE AFFECTED LEAVING THE PATIENT TEMPORARILY IMPAIRED AFTER THE INITIAL IOL IMPLANTATION. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE PATIENT COMPLAINED OF BLURRY VISION, DIFFICULTIES DRIVING, HEADACHES, AND JUST COULD NOT TOLERATE THE DIFFERENCE BETWEEN THE TWO EYES. IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED AND REPLACED WITH A DIU225 15.0 IOL. THERE WAS NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE HOWEVER, PLANNED SUTURES WERE REQUIRED FOR THE LENS EXCHANGE CLOSURE AND THEY WERE USED AS A PROPHYLACTIC MEASURE. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Discomfort; Headache; Visual Disturbances

  MAUDE report 22127461 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO BLURRY VISION AND HALOS AROUND BRIGHT LIGHTS FOLLOWING IMPLANTATION. THE PATIENT¿S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED BY THE BRIGHT LIGHTS AND HALOS. THE LENS WAS REMOVED AND REPLACED WITH AN UNKNOWN LENS DURING A SECONDARY SURGICAL PROCEDURE. THIS EVENT OCCURRED ON (B)(6) 2024, WITH THE PATIENT¿S VISION NOTED TO BE 20/70 PRE-OPERATIVELY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NO INJURIES OR ADDITIONAL MEDICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 21127153 ↗
• MalfunctionNov 11, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CONTAMINATED WHEN OPENING. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE WRAPPER (STERILE BARRIER) WAS TORN AT THE FOLD AND THE STERILITY OF THE PRODUCT WAS AFFECTED. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796930 ↗