TECNIS IOL ZCT150 (REF ZCT150U135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474552012), received between Jun 28, 2017 and Nov 14, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO DISLOCATED AND SUBLUXED IOL. IT WAS NOTED THAT THIS WAS A TEN (10) YEARS STATUS POST CATARACT EXTRACTION (CE) OF IOL. IT IS UNKNOWN IF THE ISSUE AFFECTED PATIENT'S DAILY ACTIVITIES. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND LOWER DIOPTER (AR40E,13.0D). THERE WAS NO UNPLANNED VITRECTOMY OR INCISION ENLARGEMENT REQUIRED, BUT SUTURES USED. IT IS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE, IF MEDICATION OUTSIDE OF STANDARD CARE PRESCRIBED OR IF PATIENT SEEK MEDICAL ATTENTION. THE PATIENT HAS FULLY RECOVERED. IT WAS CONFIRMED THAT THE DIRECTION FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 20691381 ↗
• MalfunctionDec 30, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED AN ORANGE OBJECT WAS NOTICED WHEN ADVANCING THE ZCT150 13.5 DIOPTER INTRAOCULAR LENS(IOL) IN THE CARTRIDGE. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS PROVIDED CONFIRMING NO PATIENT CONTACT, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE PRIMARY LENS CHOICE WITH THE SAME MODEL AND DIOPTER SIZE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8205395 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 13.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT WANTING A SYMFONY LENS INSTEAD OF A MONOFOCAL LENS. THE LENS WAS REPLACED WITH ZXT150 IOL WITH THE SAME DIOPTER SIZE. INCISION WAS ENLARGED BY 3MM DURING PROCEDURE. NO SUTURE WAS REQUIRED AND THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 6672532 ↗