TECNIS IOL DIU225 (REF DIU225U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474747142), received between Mar 22, 2022 and Jun 2, 2025 — classified as 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED LENS WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING DIFFICULTY DRIVING AND WORKING. ON THE FIRST DAY, THE UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) WAS 20/15, AND THE POST-OPERATIVE MANIFEST REFRACTION (MRX) WAS PLANO SPHERE. AT ONE WEEK, THE UCDVA DROPPED TO 20/50+1, WITH ONLY TRACE POSTERIOR CAPSULE OPACIFICATION (PCO) NOTED TO BE PRESENT, WHICH SHOWED A MYOPIC SHIFT TO -1.25 + 0.50 X 126. THE IOL WAS EXCHANGED FOR ANOTHER J&J DIU225 WITH A POWER OF 19.5. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BSCVA) PRE-OPERATIVELY WAS 20/25-2, AND POST-OPERATIVELY IT IMPROVED TO 20/15. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Posterior Capsule Opacification; Visual Disturbances; Visual Impairment

  MAUDE report 22128716 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE AND REPLACED WITH THE SAME MODEL LENS WITH 21.5D. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE LENS PLACED DID NOT WORK WELL FOR THE PATIENT, AS THE LENS WAS NOT A GOOD FIT FOR PATIENT SO IT WAS EXCHANGED FOR ANOTHER. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21886040 ↗
• MalfunctionFeb 19, 2025Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE STERILITY OF THE PRELOADED INTRAOCULAR LENS WAS COMPROMISED. ADDITIONAL INFORMATION REVEALED THAT THE PACKAGING WAS CRUSHED AND THE STERILITY SEAL WAS BROKEN. A BREACH OR POTENTIAL BREACH IN THE STERILE BARRIER OF THE DEVICE WAS NOTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413342 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED TORIC LENS WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE. IT WAS SAID THAT THE REFRACTIVE SURPRISE WAS MOST LIKELY RELATED TO PREVIOUS LASIK SURGERY. DURING A SECONDARY SURGICAL PROCEDURE, IT WAS REPLACED WITH ANOTHER J&J IOL. THE PATIENT'S PRE-OPERATIVE VISION WAS 20/30, AND POST-OPERATIVE VISION IMPROVED TO 20/20. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 20533389 ↗
• InjuryAug 29, 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 EXCHANGED DUE TO BLURRED VISION, POOR CYLINDER CORRECTION. THE PRE-OP VISUAL ACUITY (VA) 20/25, POST-OP 20/40, AND LENS EXCHANGE FOR POOR CYLINDER CORRECTION WITH ORIGINAL TORIC, HAD UNCORRECTED CYLINDER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 17647398 ↗
• MalfunctionMar 22, 2022Break; Break

  IT WAS REPORTED THAT THERE WAS AN OBVIOUS CENTRAL DEFECT IN THE INTRAOCULAR LENS (IOL) OBSERVED THE MIDDLE OF THE LENS OPTIC. THE PRE-LOAD INJECTOR DID NOT MALFUNCTION, RATHER THE DEFECT WAS PRESENT WHEN IMPLANTED. ONCE LENS WAS IN THE CAPSULE, THE DEFECT WAS FURTHER INSPECTED UNDER MICROSCOPE. THE OPTIC WAS SMOOTH ON THE SURFACE. THE SURGEON ATTEMPTED IRRIGATION/ASPIRATION AROUND THE DEFECT AND THERE WAS NO IMPROVEMENT OR CHANGE IN APPEARANCE. THE LENS WAS REMOVED, DISCARDED, AND REPLACED WITH A BACK UP LENS. THERE WAS NO ADDITIONAL SURGICAL INTERVENTIONS REQUIRED. THE PATIENT IS RECOVERING WELL WITH NO COMPLICATIONS POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13850523 ↗