TECNIS IOL DIU525 (REF DIU525U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474749528), received between Jul 6, 2022 and May 9, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CATARACT EXTRACTION PROCEDURE WHICH INVOLVED A +21.5 DIU525 INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD) AND A +21.5 DIU450 LENS IN THE LEFT EYE (OS). POST-OPERATIVELY, THE PATIENT EXPERIENCED DIFFICULTY SEEING AT A DISTANCE WITH THE RIGHT EYE, ACHIEVING GOOD VISION ONLY FOR COMPUTER DISTANCE AND CLOSER. DURING A RECENT FOLLOW-UP VISIT, VISUAL ACUITY MEASUREMENTS WERE RECORDED AS 20/125 FOR DISTANCE AND 20/30 FOR INTERMEDIATE IN THE RIGHT EYE. HER POST-OPERATIVE MANIFEST REFRACTION (MRX) IS -1.75 +1.50 X 045 OD. THE PATIENT HAS BEEN UNABLE TO TOLERATE THE ANISOMETROPIA AND HAS REPORTED FREQUENT HEADACHES. PHYSICIAN PLANS TO PERFORM AN INTRAOCULAR LENS EXCHANGE IN THE RIGHT EYE WITH A MONOFOCAL TORIC ZCU LENS BUT IS FACING CHALLENGES WITH LENS ALIGNMENT DUE TO THE PATIENT'S POOR DILATION. THE PHYSICIAN CANNOT SEE TORIC MARKINGS ON THE LENS FOR ALIGNMENT, BUT THE PHYSICIAN SUSPECTS THE LENS IS NOT AT THE DESIRED AXIS. PHYSICIAN WAS GOING TO AIM FOR AS CLOSE TO PLANO OR FIRST MINUS AFTER PLANO IF IT IS NOT MORE MINUS THAN -0.30. THE PATIENT DOES NOT HAVE POSTERIOR CAPSULE OPACIFICATION, AND OTHER ASSESSMENTS SHOW A QUIET ANTERIOR CHAMBER, CLEAR

  Patient problems: Corneal Edema; Discomfort; Headache; Visual Impairment

  MAUDE report 21999192 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. THE REPORTED ISSUE WAS UNEXPECTED POST-OPERATIVE REFRACTION. THE OUTCOME WAS SIGNIFICANTLY AFFECTING THE PATIENT'S DAILY ACTIVITIES. ACCOUNT INDICATED THAT THE PATIENT WAS TEMPORARILY IMPAIRED. THERE WAS NO VITRECTOMY OR SUTURES, NO INCISION ENLARGEMENT AND NO DELAY IN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14939947 ↗