TECNIS IOL DIU225 (REF DIU225U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474747074), received between Jan 20, 2022 and Feb 17, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE PATIENT EXPERIENCED INTOLERABLE REFRACTIVE OUTCOME DUE TO THEIR POOR UNCORRECTED NEAR VISION. DOCTOR REPORTED REPEAT KERATOMETRY SHOWS CORNEAL ASTIGMATISM HAS CHANGED NOW NOT REQUIRING A TORIC LENS. THEREFORE, THE DOCTOR PLANNED TO REMOVE THE IOL AND REPLACE IT WITH A HIGHER POWER MONOFOCAL WITH A TARGET OF -250. THROUGH FOLLOW-UP THE CUSTOMER CONFIRMED THAT THE IOL WAS SUBSEQUENTLY EXPLANTED. THEY DID NOT PROVIDE THE REPLACEMENT LENS INFORMATION. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, SUTURES OR MEDICATION OUTSIDE THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 24370682 ↗
• MalfunctionOct 31, 2025Contamination; Contamination

  IT WAS REPORTED THAT A PRELOADED, TORIC II MONOFOCAL INTRAOCULAR LENS (IOL) INJECTOR WAS FOUND TO HAVE PLASTIC DEBRIS AT THE NOZZLE TIP DURING THE INSERTION OF A LENS INTO A PATIENT'S RIGHT EYE (OD). IT WAS CONFIRMED THAT THE IOL WAS NOT STUCK. THE LENS WAS NOT FULLY ADVANCED, AND THE INJECTOR WITH THE LENS WAS REMOVED FROM THE EYE UPON DETECTION OF THE DEBRIS. THE PATIENT DID NOT SUSTAIN ANY INJURY, AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTIONS WERE NECESSARY. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THE DEBRIS, DESCRIBED AS RESEMBLING A SMALL PIECE OF BLUE POLYESTER FABRIC, ALONG WITH THE LENS. IT WAS NOTED THAT THE ISSUE WAS NOT DUE TO USER ERROR. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439338 ↗
• MalfunctionJan 21, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE. THE SURGEON REPORTED THE TRAILING HAPTIC WAS SEVERED BY THE INJECTOR, WHICH WAS REALIZED AFTER THE LENS WAS IN THE EYE. UPON INSERTION THE SURGEON DID NOT REPORT RESISTANCE. THE SURGEON CUT THE LENS OUT OF THE EYE AND REPLACED IT WITH ANOTHER JOHNSON AND JOHNSON IOL (DIFFERENT MODEL, DIV225, SAME DIOPTER) DURING THE SAME PROCEDURE. THERE WAS NO DELAY IN SURGERY, NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED, AND THERE WAS NO PATIENT INJURY. THE PATIENT IS OK. THE IOL WAS DISCARDED. THE ACCOUNT USED BALANCED SALT SOLUTION (BSS) WHICH WAS AT ROOM TEMPERATURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13323819 ↗
• InjuryJan 20, 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 RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO RESIDUAL HYPEROPIA. THE ISSUE WAS OBSERVED DURING POST-OPERATIVE VISIT. BLURRY VISION WAS ALSO REPORTED SECONDARY TO HYPEROPIA AND THE PATIENT DECIDED ON GLASSES OR 10C EXCHANGE. VISUAL ACUITY PRE-OPERATIVE: 20/20 WITH CORRECTION AND VISUAL ACUITY POST-OPERATIVE: 20/20 WITH CORRECTION 20/40 WITHOUT CORRECTION. PATIENT OUTCOME: +1.00 +0.75 X172. THERE WERE NO MEDICAL/SURGICAL INTERVENTIONS REQUIRED AND NO DELAY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13311181 ↗