TECNIS IOL DIU150 (REF DIU150U245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474746633), received between May 25, 2023 and May 6, 2025 — classified as 3 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 6, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO MECHANICAL FAILURE, WHICH WAS IDENTIFIED DURING THE POST-OPERATIVE EXAMINATION. THE LENS WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON IOL. NO INJURY AND INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965353 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS EXPLANTED DUE TO A MECHANICAL COMPLICATION RELATED TO VISUAL ACUITY. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER, A J&J IOL. NO INJURY OR ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21358766 ↗
• InjurySep 8, 2023Adverse 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 A PATIENT'S RIGHT EYE DUE TO SEVERE POSITIVE AND NEGATIVE DYSPHOTOPSIA. THE SYMPTOMS WERE DEBILITATING TO THE PATIENT. A NON-JOHNSON & JOHNSON LENS OF 24.0 DIOPTER WAS USED AS A REPLACEMENT. NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED, AND NO PATIENT INJURY REPORTED. THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 17716514 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DIU150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF POOR VISION WITH THE DIU150 IOL. REPLACEMENT LENS WAS A ZCB00 18.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS STABLE POST-OPERATIVELY WITH RESOLVED SYMPTOMS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 17007858 ↗