TECNIS IOL ZCU150 (REF ZCU150U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474657823), received between Jun 9, 2021 and May 27, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Opacification” (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 18, 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.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MYOPIC REFRACTIVE OUTCOME FOLLOWING IMPLANTATION OF A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZCU150, IN THE PATIENT¿S LEFT EYE. IT IS UNKNOWN WHETHER THE EVENT IMPACTED ACTIVITIES OF DAILY LIVING. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL WITH A 1.5 D DIFFERENCE (ZCU150, 20.0 D). THE PATIENT¿S OUTCOME STATUS AND POSTOPERATIVE REFRACTION FOLLOWING IMPLANTATION OF THE REPLACEMENT LENS REMAIN UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25310762 ↗
• MalfunctionApr 14, 2023Material Opacification; Material Opacification

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A BROWN SPOT ON IT AND WAS NOT USED. IT IS UNKNOWN IF THE PRODUCT HAD PATIENT CONTACT. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741199 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BLURRY VISION IN BOTH EYES (OU) RESULTING FOR THE NEED TO EXPLANT BOTH INTRAOCULAR LENSES (IOLS). THE IOLS WERE EXPLANTED ON SEPARATE DAYS AND REPLACED WITH NON-JOHNSON & JOHNSON IOLS. THE INCISION WAS ENLARGED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE (OS).

  Patient problems: Blurred Vision

  MAUDE report 14691797 ↗
• InjuryJun 9, 2021Unstable; Unstable

  RECEIVED REPORT INDICATING THE INTRAOCULAR LENS (IOL) ROTATED POST-OP AND HAD TO BE EXPLANTED. THE IOL ROTATED FROM 100 DEGREES TO 125 DEGREES. THE DOCTOR RAN ASTIGMATISM FIX, THE RECOMMENDATION WAS TO EXCHANGE IT. THE REPLACEMENT IOL WAS A DIFFERENT MODEL ZCU225 AND HIGHER DIOPTER 22.0. THE EXPLANTED IOL WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963936 ↗