TECNIS IOL ZCT225 (REF ZCT225U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474552807), received between Sep 12, 2016 and Aug 27, 2021 — classified as 2 injuries.

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.

• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO PATIENT HAVING ANISOMETROPIA VISION. VITRECTOMY AND SUTURES WERE NOT REQUIRED. PATIENT HAS FULLY RECOVERED. VISUAL ACUITY READINGS PROVIDED AS PRE-OPERATIVE 20/80 AND POST-OPERATIVE 20/40. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12380344 ↗
• InjurySep 12, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT EXPERIENCED POST-OPERATIVE RESIDUAL REFRACTIVE ERROR AFTER IMPLANTATION OF A MODEL ZCT225 23.5 DIOPTER INTRAOCULAR LENS (IOL). THE LENS WAS EXPLANTED AND REPLACED WITH A MODEL Z9002 22.5 DIOPTER LENS. THERE WAS NO PATIENT INJURY; THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 5944848 ↗