TECNIS IOL ZCU150 (REF ZCU150U240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474657878), received between Jan 15, 2021 and Feb 28, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2022Break; Break

  IT AS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC MALFUNCTIONED. THERE WAS NO ADVERSE EVENT THAT OCCURRED. THE SUSPECT LENS IS NOT BEING RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621249 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN INSERTING AN INTRAOCULAR LENS (IOL) INTO A PATIENT¿S RIGHT EYE (OD), IT WENT THROUGH THE BACK OF THE ARRORA CAPSULE, RESULTED IN CAPSULE TEAR. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. PATIENT WAS REPORTED TO BE HAPPY WITH THE OUTCOME. THERE WERE NO MEDICAL/SURGICAL INTERVENTIONS REQUIRED AND NO DELAY WAS REPORTED. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY WAS OD COUNT FINGERS AT 4FT. THE PATIENT'S POST-OPERATIVE VISUAL ACUITY WAS 20/40 +1 UNCORRECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 13300406 ↗
• InjuryApr 1, 2021Adverse 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 IN A SECONDARY SURGICAL PROCEDURE DUE TO THE POWER MISS AND BLURRY VISION. THERE WAS NO SURGICAL INTERVENTION SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. A REPLACEMENT LENS OF THE SAME MODEL, BUT A DIFFERENT DIOPTER (27.0) WAS USED. THE PATIENT OUTCOME WAS REPORTED TO BE GOOD AND NO INJURY WAS REPORTED. THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11600789 ↗
• InjuryMar 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE (OD) IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT EXPERIENCING PROBLEMS WITH VISION. A REPLACEMENT LENS OF THE SAME MODE, BUT DIFFERENT DIOPTER (22.5 D) WAS USED. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED AND NO PATIENT INJURY REPORTED. IT WAS REPORTED THAT THE PATIENT IS DOING WELL POST-OP. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD A BILATERAL LENS IMPLANTS AND THE ISSUE REPORTED ON BOTH EYES. HOWEVER, THE LENS IN THE LEFT EYE REMAINS IMPLANTED TO DATE. THIS EMDR REPORT PERTAINS TO THE LENS IN THE RIGHT EYE OF THE PATIENT.

  Patient problems: Blurred Vision

  MAUDE report 11427495 ↗
• MalfunctionJan 15, 2021Break

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS LOADED INTO THE INSERTER WITHOUT THE PLUNGER BEING SECURELY ATTACHED. HOWEVER, THE LENS WAS NOTED TO BE DAMAGED AFTER IT WAS INSERTED INTO PATIENT EYE AND WAS CUT OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182418 ↗