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TECNIS IOL ZCT600 (REF ZCT600U150)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 15.0D 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
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474604063), received between Jun 9, 2017 and Jul 7, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Scratched Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

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

  • InjuryJul 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO MECHANICAL COMPLICATION OF THE LENS. ANOTHER UNKNOWN LENS WAS USED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12132475 ↗
  • MalfunctionJun 9, 2017Scratched Material; Scratched Material

    IT WAS REPORTED THAT A SCRATCH WAS NOTICED ON AN INTRAOCULAR LENS (IOL) WHEN REMOVING IT FROM THE PACKAGE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 6629038 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

All LENS, INTRAOCULAR, TORIC OPTICS devices →

Sources and updates

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