TECNIS IOL DIU225 (REF DIU225U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474747067), received between Jul 12, 2022 and Mar 11, 2025 — classified as 4 injuries, 4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S EYE. THE IOL HAD A DEFECT IN THE PATIENT¿S VIEW. THE DOCTOR WAS ABLE TO FOLD THE LENS AND THEN REMOVE IT. REPORTEDLY, THE CUSTOMER SAVED THE IOL IN A STERILE SPECIMEN CUP TO RETURN TO JOHNSON AND JOHNSON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580110 ↗
• MalfunctionJan 27, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD VISIBLE FLAWS IN THE FIELD OF VISION. THE ISSUE WAS NOTICED AFTER THE IOL WAS IMPLANTED INTO THE PATIENT¿S OPERATIVE EYE. THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH A BACKUP OF THE SAME MODEL BUT DIFFERENT DIOPTER. MODEL: DIU225 17.0 DIOPTER. 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 21245705 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. DURING POST OPERATIVE EXAM THE PATIENT REPORTED BLURRY VISION AND HYPEROPIC OUTCOME. THE SYMPTOMS PERSISTED APPROXIMATELY FOUR WEEKS. THE IOL WAS EXPLANTED AND REPLACED WITH THE SAME JNJ MODEL DIU225 17.0 DIOPTER. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT¿S DAILY ACTIVITIES WERE NOT IMPACTED BY THIS EVENT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR DELAY IN PROCEDURE. NO MEDICATION WAS PRESCRIBED OUTSIDE THE STANDARD OF CARE. THE PATIENT HAS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 20348240 ↗
• MalfunctionApr 25, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) PLUNGER WENT SIDEWAYS THROUGH THE INSERTER WITH THE LENS STUCK ON IT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT AFTER INJECTING BALANCED SALT SOLUTION (BSS) AND ADVANCING, THE LENS CAME OUT FROM THE SIDE OF THE CARTRIDGE. THERE WAS DAMAGE TO THE LENS. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187759 ↗
• InjuryJul 10, 2023Unstable; Unstable

  IT WAS REPORTED THAT DIU225 INTRAOCULAR LENS WAS EXPLANTED DUE TO SIGNIFICANT ROTATION WHICH WAS OBSERVED IN POST-OPERATIVE EXAMINATION. PATIENT HAD MARKED MOVEMENT DISORDER AND ALSO HAD A FALL AND STRUCK HER HEAD IN THE FIRST WEEK POST-OPERATIVELY. THERE WAS NO INCISION ENLARGEMENT. NO REQUIREMENT OF SUTURES AND VITRECTOMY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17294564 ↗
• InjuryJun 16, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) ROTATED IN THE PATIENT¿S LEFT EYE RESULTING IN BLURRY VISION. THE IOL WAS REPLACED WITH A DIFFERENT JNJ MODEL DIB00. POST OPERATIVELY THE PATIENT WAS REPORTED AS FINE. THE EXPLANTED LENS IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 17144133 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING REFRACTIVE SURPRISE IN THEIR RIGHT EYE (OD) REQUIRING AN EXPLANT OF THE INTRA-OCULAR LENS (IOL). NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. THE PATIENT STATUS IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15332202 ↗
• MalfunctionJul 12, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DIFFICULT TO DEPLOY AND THE HAPTIC WAS STUCK. THE LENS WAS PUSHED THROUGH INTO THE OPERATIVE EYE, BUT HAD TO BE ROTATED INTO PLACE. NO OTHER INTERVENTION WAS REQUIRED AND THE LENS REMAINS IMPLANTED. THE PATIENT WAS DOING FINE POST-OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988414 ↗