TECNIS IOL DIU225 (REF DIU225U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474747081), received between May 23, 2022 and Apr 17, 2025 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIU225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT HAD BLURRY VISION AND RESIDUAL ASTIGMATISM. SHE CANNOT READ THE CAPTIONS ON HER TV AND VISION IS OVERALL STILL BLURRY. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCU225 18.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE HOWEVER, A CAPSULAR TENSION RING, 11.0, WAS USED TO HELP STABILIZE THE CAPSULE. BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCV) PRE-OPERATIVE WAS 20/40 AND POST-OPERATIVE WAS 20/50. PATIENT VISUAL ACUITY POST-LENS EXCHANGE AT 1 DAY POST OP VISIT WAS REPORTED AS 20/50SC DISTANCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21861823 ↗
• MalfunctionOct 5, 2023Unstable; Unstable

  IT WAS REPORTED THAT AFTER THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED (EVALUATION LENS), THE PATIENT HAD 20/20 VISUAL ACUITY ON DAY ONE, BUT AT ONE WEEK POST-IMPLANTATION, THE LENS HAD ROTATED 20 DEGREES. THE PATIENT WENT BACK FOR LENS ROTATION SURGERY ON (B)(6) 2023, WHICH WENT WELL. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17880383 ↗
• InjurySep 30, 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 THE PATIENT'S LEFT EYE DUE TO REFRACTIVE SURPRISE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15515366 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REFRACTIVE SURPRISE IN THEIR LEFT EYE (OS) REQUIRING AN EXPLANT OF THE INTRAOCULAR LENS (IOL). NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WAS REQUIRED. THE PATIENT IS STATED TO BE TEMPORARILY IMPAIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15376475 ↗
• MalfunctionMay 23, 2022Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DEFECTIVE AND THE INSERTER WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14479792 ↗