Skip to content

TECNIS IOL ZCT600 (REF ZCT600U180)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 18.0D CYL6.00 · Class 3 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474604124), received between Aug 24, 2016 and Aug 13, 2019 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • No Code Available2
  • Blurred Vision1
  • Visual Disturbances1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZCT600 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO BLURRY AND VISUAL DISTURBANCES. THE PATIENT VISUAL ACUITY PRE-OPERATIVE WAS 20/60 AND POST-OPERATIVE WAS 20/25. A REPLACEMENT LENS IS A ZCT600 AT A LOWER DIOPTER. INCISION ENLARGEMENT ALONG WITH SUTURE WERE PERFORMED DURING THE SURGERY. THE CUSTOMER INDICATED THAT THE IOL WAS DISCARDED BY THE SURGEON. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision; No Code Available; Visual Disturbances

    MAUDE report 8887152 ↗
  • InjuryAug 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 18.0 DIOPTER ZCT600 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AND REPLACED WITH A 18.5 DIOPTER ZCT300 IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES OR OTHER PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 5901601 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

All LENS, INTRAOCULAR, TORIC OPTICS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.