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TECNIS IOL DIU450 (REF DIU450U245)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 24.5D CYL4.50 · 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 05050474748996), received between Feb 10, 2023 and Feb 10, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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 18, 2026.

Most reported problems

Device problems

  • Unstable1

Patient problems

  • Zonular Dehiscence1

Recent adverse event reports

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

  • InjuryFeb 10, 2023Unstable; Unstable

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE. THE CAPSULE WAS NOT STABLE SO ANOTHER JOHNSON AND JOHNSON IOL (DIFFERENT MODEL, ZA9003, SAME DIOPTER) WAS PLACED IN THE SULCUS INSTEAD. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OPERATIVE EXAM. THE PATIENT WAS ORIGINALLY SCHEDULED FOR AN IOL REPOSITIONING. THE PATIENT'S UNSPECIFIED SYMPTOMS LASTED FOR TWO DAYS. THERE WAS NO INCISION ENLARGEMENT, SUTURE, OR VITRECTOMY REQUIRED. THERE WAS NO DELAY IN PROCEDURE AND NO PATIENT INJURY. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Zonular Dehiscence

    MAUDE report 16359139 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

All LENS, INTRAOCULAR, TORIC OPTICS devices →

Sources and updates

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