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TECNIS IOL ZCT450 (REF ZCT450U220)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 22.0D 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 05050474603028), 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 RIGHT EYE OF A (B)(6)YEAR-OLD (B)(6) PATIENT. AT THE TWO WEEKS POST-OP VISIT OF THE COMPANION LENS IMPLANT, IT WAS NOTED THAT A LENS MISALIGNMENT OF 12 DEGREES FROM THE ORIGINAL POSITION WAS NOTED. THE LENS WAS ORIGINALLY PLACED AT 102 DEGREES AND WAS NOTED AT 90 DEGREES DURING THE SLIT LAMP EXAM. THERE WERE NO PATIENT COMPLICATIONS OR RELATED INJURIES. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS REPOSITIONING WAS PLANNED FOR (B)(6) 2016; HOWEVER, THE DOCTOR PERFORMED THE LENS REPOSITIONING ON (B)(6) 2016. REPORTEDLY THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT ALSO HAS A LENS IMPLANTED IN HER LEFT EYE. A SEPARATE MDR WILL BE FILED FOR THIS LENS.

    Patient problems: No Code Available

    MAUDE report 6192049 ↗

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Sources and updates

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