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TECNIS IOL DIU300 (REF DIU300U050)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 05.0D CYL3.00 · 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 05050474747425), received between Dec 15, 2022 and Dec 15, 2022 — classified as 1 malfunction.

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

  • Break1
  • Mechanical Jam1

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.

  • MalfunctionDec 15, 2022Break; Mechanical Jam; Break; Mechanical Jam

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD LOADING ERROR. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE HAPTIC WAS CURLING WHEN TRYING TO ADVANCE, THE LENS WAS GETTING STUCK IN THE INJECTOR AND NOT LOADING CORRECTLY. THERE WAS NO PATIENT CONTACT AND NO INTERVENTION WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15984676 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

All LENS, INTRAOCULAR, TORIC OPTICS devices →

Sources and updates

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