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TECNIS IOL DIU450 (REF DIU450U115)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 11.5D 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 05050474748736), received between Jul 21, 2022 and Jul 21, 2022 — 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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Visual Impairment1

Recent adverse event reports

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

  • InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO DISSATISFIED PATIENT AND RESIDUAL REFRACTIVE ERROR THAT IS UNACCEPTABLE. IT WAS STATED THAT DOCTOR USED LENSTAR BIOMETER AND THE QUANTAL ASCAN. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Visual Impairment

    MAUDE report 15080718 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

All LENS, INTRAOCULAR, TORIC OPTICS devices →

Sources and updates

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