TECNIS IOL DIU225 (REF DIU225U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474747197), received between Jan 26, 2022 and Aug 4, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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.

• MalfunctionAug 4, 2026Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129013 ↗
• MalfunctionNov 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE. DURING THE PROCEDURE THE CUSTOMER OBSERVED THE HAPTICS WERE STUCK TOGETHER WHICH THEY DESCRIBED AS ¿KISSING HAPTICS¿. TWO INSTRUMENTS WERE REQUIRED TO RELEASE THE HAPTICS. THIS ACTION TOOK SOME TIME. DESPITE THIS, THE SURGEON WAS ABLE TO COMPLETE THE CASE WITHOUT FURTHER COMPLICATIONS. ALL THE STEPS FOR PREPPING THE IOLS WERE COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641015 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO REFRACTIVE SURPRISE. THE LENS WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL MODEL DRT225 23.0 DIOPTER. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 21270631 ↗
• MalfunctionOct 1, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS(IOL) HAD A NOTICEABLE SCRATCH ON THE LENS AND THE LES WAS REMOVED FROM THE PATIENT'S EYE AND REPLACED WITH THE SECOND BACKUP LENS IN THE SAME PROCEDURE. THERE WERE NO ISSUES WITH SECOND LENS. THE ISSUE WAS IDENTIFIED DURING LENS IMPLANTATION. THERE WAS NO HARM TO PATIENT. DAILY ACTIVITIES WERE NOT AFFECTED. NO FURTHER ATTENTION WAS NEEDED. THERE WAS NO DELAY IN PROCEDURE AND NO SUTURES WERE REQUIRED. THE DIRECTIONS WERE FOLLOWED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS A SCRATCH ON THE OPTIC AND SURGEON BELIEVED THAT IT WAS PRODUCT QUALITY ISSUE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348204 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE) DUE TO COMPLAINTS OF REFRACTIVE SURPRISE AND REPLACED WITH A DIB00 20.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY REQUIRED. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 16212397 ↗
• InjuryOct 4, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT WHILE INSERTING THE INTRAOCULAR LENS (IOL) INTO PATIENT'S RIGHT EYE IT WAS TIGHT AND THE CAPSULE BROKE. THE INCISION WAS ENLARGED AND A VITRECTOMY WAS PERFORMED. ONE STITCH WAS PLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 15541259 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POOR QUALITY OF VISION DESCRIBED AS BEING HAZY AND FLICKERING IN THEIR LEFT EYE (OS) RESULTING IN THE NEED FOR AN EXPLANT. THE INTRAOCULAR LENS (IOL) WAS REPLACED WITH A MODEL ZCU225, 22.5 DIOPTER IOL. THERE WAS NO REPORTED PATIENT INJURY AND NO OTHER SURGICAL OR MEDICAL INTERVENTION REQUIRED. PATIENT IS REPORTED TO BE DOING MUCH BETTER AFTER THE IOL EXCHANGE (NO 20/20 UNCORRECTED). PRE-OP UNCORRECTED VISUAL ACUITY- UNKNOWN. BEST CORRECTED PRE-OP 20/30. POST-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY: 20/40 AND 20/25-2. INTENDED/TARGETED POST-OPERATIVE REFRACTION: PLANO. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15143206 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE DUE TO REFRACTIVE ERROR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 13354436 ↗