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TECNIS IOL ZCT450 (REF ZCT450U225)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 22.5D CYL4.50 · 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 05050474603035), received between Dec 20, 2016 and Dec 20, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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

  • Unintended Movement1

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.

  • InjuryDec 20, 2016Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) FEMALE PATIENT. AT THE TWO WEEKS POST-OP VISIT, A LENS MISALIGNMENT OF 23 DEGREES FROM THE ORIGINAL POSITION WAS NOTED. THE LENS ORIGINALLY PLACED AT 105 DEGREES WAS NOTED AT 82 DEGREES DURING THE SLIT LAMP EXAM. THERE WERE NO PATIENT COMPLICATIONS OR RELATED INJURIES. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE LENS WAS REPOSITIONED ON (B)(6) 2016. REPORTEDLY THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT ALSO HAS A LENS IMPLANTED IN HER RIGHT EYE. A SEPARATE MDR WILL BE FILED FOR THIS LENS.

    Patient problems: No Code Available

    MAUDE report 6192048 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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