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TECNIS IOL DIU225 (REF DIU225U265)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 26.5D CYL2.25 · 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 05050474747265), received between Feb 23, 2023 and Feb 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation1

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.

  • MalfunctionFeb 23, 2023Material Fragmentation; Material Fragmentation

    IT WAS INITIALLY REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAS PATIENT CONTACT AND WAS BEING RETURNED. NO EVENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023, WHICH REPORTED THAT THE IOL HAPTIC WAS TORN OFF AS IT WAS INSERTED IN THE PATIENT'S LEFT EYE. THE LENS WAS FULLY INSERTED. THERE WERE NO DELAYS IN SURGERY BEFORE ATTEMPTING TO ADVANCE THE LENS. THE ISSUE WAS NOT DUE TO USE ERROR. THE LENS WAS REMOVED AND ANOTHER JOHNSON AND JOHNSON LENS WAS INSERTED AS REPLACEMENT (SAME MODEL AND DIOPTER). NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16431744 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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