TECNIS IOL DIU225 (REF DIU225U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474747128), received between Oct 6, 2022 and Sep 15, 2026 — classified as 2 injuries, 2 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. 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.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a preloaded monofocal intraocular lens (IOL) was implanted in the patient's right eye. Initial information indicated that the lens was scheduled for explantation on (b)(6) 2026, for an unspecified reason. Follow-up information later confirmed that the explant procedure was performed due to blurred vision and subjective visual disturbances. Additional information revealed that the event occurred in (b)(6) 2026, approximately one week after implantation, when the patient experienced unsatisfactory visual outcomes. The implanted lens was reported to have significantly overcorrected the patient's astigmatism, resulting in blurred vision at all distances. The patient reported an inability to perform activities that could be completed prior to surgery, including near and distance reading and driving. The explantation was attributed to blurred vision at all distances associated with overcorrection of astigmatism.The lens was explanted as planned and replaced with a DIU150 intraocular lens (+19.5 D). No additional or unplanned surgical interventions, including YAG capsulotomy, unplanned vitrectomy, incision enlargement, or suture placement, were required during the pro

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 50775786 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT AFTER FULL IMPLANTATION OF THE PRELOADED TORIC INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, A DEFECT WAS FOUND ON THE LENS. THE LENS WAS REMOVED DURING THE SAME PROCEDURE. UNPLANNED SUTURES AND AN UNPLANNED INCISION ENLARGEMENT WAS REQUIRED. NO VITRECTOMY WAS NEEDED. THERE WAS A 45 MINUTE DELAY IN PROCEDURE. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19282996 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DIU225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF HYPEROPIC OUTCOME, MONOCULAR DOUBLE VISION WITH A SHADOW AT THE TOP OF HIS MAIN VISION, AND DIFFICULTY WITH DISTANCE VISION. THE REPLACEMENT LENS WAS A DIU150 20.5 DIOPTER IOL. PATIENT OUTCOME POST-LENS EXCHANGE IS UNKNOWN. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 18135689 ↗
• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE DUE TO BENT/ BROKEN HAPTIC. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552429 ↗