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TECNIS IOL ZCT525 (REF ZCT525U135)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 13.5D CYL5.25 · 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 05050474603448), received between Jul 19, 2017 and Jul 19, 2017 — 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

  • Appropriate Device Problem Term/Code Not Available1

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.

  • InjuryJul 19, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT A ZCT525 13.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED ON (B)(6) 2017. REPORTEDLY, LENS WAS DEFECTIVE; HOWEVER, NO SPECIFICS ON THE LENS WAS PROVIDED. THE LENS WAS REPLACED WITH A ZCT400 IOL WITH THE SAME DIOPTER SIZE. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE, AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 6727113 ↗

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Sources and updates

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