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TECNIS IOL ZCU525 (REF ZCU525U215)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 21.5D CYL5.25 · Class 3 · Implant

All models of TECNIS IOL (1344)

Data updated Oct 18, 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 05050474664319), received between Aug 11, 2020 and Aug 11, 2020 — 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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A TECNIS TORIC II INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DUE TO THE NEED FOR NEW LENS POWER FOR PATIENT TO REACH THE INTENDED VISION. THE REPLACEMENT LENS IS THE SAME MODEL, BUT HIGHER DIOPTER (22.5) IOL. THERE WERE NO SUTURES OR INCISION ENLARGEMENT REQUIRED. REPORTEDLY, PATIENT IS DOING WELL POST-OPERATION. NO FURTHER INFORMATION PROVIDED.

    Patient problems: No Code Available

    MAUDE report 10393806 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

All LENS, INTRAOCULAR, TORIC OPTICS devices →

Sources and updates

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