TECNIS IOL DIU150 (REF DIU150U250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474746640), received between Oct 6, 2022 and Jan 18, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A FOREIGN MATERIAL. A PLASTIC PIECE CAME OUT OF THE SIMPLICITY INJECTOR. THE ISSUE WAS NOTICED AFTER THE LENS WAS IMPLANTED INTO THE EYE. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER HENCE THERE WAS SOME DELAY IN THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED SUCH AS AN INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THE PATIENT¿S DAILY ACTIVITIES WERE NOT IMPACTED BY THIS EVENT. AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186373 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MONOFOCAL TORIC INTRAOCULAR LENS WAS EXCHANGED ON (B)(6) 2024 DUE TO AN UNDERPOWERED TORIC. THE LENS HAS BEEN DISPOSED OF, SO WE WILL NOT BE ABLE TO SEND IT BACK. ADDITIONAL INFORMATION REVEALED IT HAPPEN DUE TO EITHER HUMAN ERROR IN THE QUALITY OF MEASUREMENT OR OCULAR SURFACE VARIABILITY, WITH NO ISSUES POST-OP. THE PATIENT WAS SEEN POW 1 S/P TORIC IOL EXCHANGE AND IS PLEASED WITH HER VISION AND NOTES IMPROVEMENT. FURTHER ADDITIONAL INFORMATION SUGGESTS THE PATIENT HAD BLURRED VISION AND OPTICAL DISTORTION SECONDARY TO RESIDUAL UNCORRECTED ASTIGMATISM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 19261861 ↗
• InjuryOct 6, 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 A REFRACTIVE SURPRISE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW-UP, THE CUSTOMER INDICATED THAT THE REPLACEMENT LENS INFORMATION WAS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 15548026 ↗