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TECNIS IOL ZCT600 (REF ZCT600U185)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 18.5D CYL6.00 · Class 3 · Implant

All models of TECNIS IOL (1344)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474604131), received between Apr 29, 2021 and Apr 29, 2021 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Endophthalmitis1
  • Halo1
  • Uveitis1
  • Visual Disturbances1
  • Visual Impairment1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZCT600 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO PATIENT COMPLAINING OF BLACK CIRCLES AND HALOS. NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE PERFORMED. THE REPLACEMENT LENS USED IS A NON JOHNSON AND JOHNSON SURGICAL VISION LENS. PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Endophthalmitis; Halo; Uveitis; Visual Disturbances; Visual Impairment

    MAUDE report 11750200 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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