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TECNIS IOL DIU450 (REF DIU450U205)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 20.5D 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474748910), received between Nov 1, 2021 and Nov 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

  • Crack1
  • Scratched Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 1, 2021Crack; Scratched Material; Crack; Scratched Material

    IT WAS REPORTED THAT A DIU450 MODEL INTRAOCULAR LENS(IOL) CAME OUT OF INJECTOR SIDEWAYS AND SCRATCHED THE LENS ON THE WAY OUT OF THE INJECTOR. THERE WAS NO PATIENT CONTACT. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12734219 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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