TECNIS IOL DIU375 (REF DIU375U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474748361), received between Jul 31, 2025 and Dec 8, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO "WRONG POWER". IT IS UNKNOWN IF THE PATIENT HAD A LOSS OF 2 OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA). ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIU375 21.0 DIOPTER). THERE WAS NO PATIENT INJURY. NO UNPLANNED SURGICAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. THERE ARE NO PLANNED SURGICAL INTERVENTIONS. THE PATIENT¿S OUTCOME INITIALLY REPORTED AS FINE; HOWEVER LATER IT WAS INDICATED TO BE UNKNOWN AND IT IS UNKNOWN IF THE REPLACEMENT LENS IMPROVED OR RESOLVED THE PATIENT'S SYMPTOMS. THERE IS NO INFORMATION AVAILABLE REGARDING WHETHER THE INCORRECT LENS POWER WAS DUE TO A CALCULATION ERROR OR A USE ERROR. IT WAS CONFIRMED THAT THE LENS DID NOT MALFUNCTION, ITS POWER MATCHED THE INTENDED SPECIFICATION, AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23753075 ↗
• InjuryJul 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A MONOFOCAL TORIC INTRAOCULAR LENS IMPLANTED IN A LARGER CAPSULOTOMY, LEADING TO THE HAPTICS RUBBING AGAINST THE IRIS. THIS HAS RESULTED IN SIGNIFICANT PIGMENT DISPERSION AND ELEVATED INTRAOCULAR PRESSURE IN THE PATIENT. THE LENS REMAINS IMPLANTED IN THE PATIENT'S RIGHT EYE AND CANNOT BE REMOVED DUE TO THE POSITIONING OF THE HAPTICS WITHIN THE LARGE CAPSULOTOMY. THE TIMING OF THE EVENT, WHETHER DURING INSERTION OR POST-OPERATION, IS UNSPECIFIED. WHILE THE SYMPTOMS ARE DESCRIBED AS SIGNIFICANT, IT IS NOT CLEAR WHETHER THEY AFFECT THE PATIENT¿S DAILY ACTIVITIES. NO SURGICAL OR MEDICAL INTERVENTIONS HAVE BEEN UNDERTAKEN OR ARE PLANNED. THE PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Pigment Dispersion Syndrome

  MAUDE report 22682883 ↗