TECNIS IOL DIU375 (REF DIU375U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474748323), received between Dec 29, 2021 and Sep 25, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Eye Injury

  MAUDE report 50892624 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PHYSICIAN PLANNED EXPLANTATION OF A TORIC INTRAOCULAR LENS, WITH REPLACEMENT BY A DIFFERENT TORIC LENS, SCHEDULED FOR (B)(6), 2026. THE REASON FOR EXPLANT WAS NOT SPECIFIED. ON (B)(6), 2026, IT WAS LEARNED THAT THE LENS HAD BEEN EXPLANTED; HOWEVER, THE EXPLANTATION DATE AND REPLACEMENT LENS DETAILS WERE NOT CONFIRMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 24933799 ↗
• InjuryAug 15, 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 RIGHT EYE DUE TO RESIDUAL ASTIGMATISM, FLICKERING, FLOATERS, BLURRY AND NEEDS READERS FOR NEAR, UNHAPPY WITH NEAR VISION. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIU225 20.0 DIOPTER SN# (B)(4) WAS IMPLANTED AS A REPLACEMENT. NO OTHER INTERVENTIONS PERFORMED. NO PATIENT POST-EXPLANT INJURIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 15230236 ↗
• MalfunctionDec 29, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS CUT AND REMOVED FROM THE PATIENT'S OPERATIVE EYE AS IT WAS MISSING A HAPTIC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13115393 ↗