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TECNIS IOL DIU150 (REF DIU150U140)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 14.0D CYL1.50 · Class 3 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474746428), received between Nov 19, 2021 and Nov 8, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Inaccurate Delivery1
  • Material Fragmentation1
  • Scratched Material1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 8, 2023Scratched Material; Scratched Material

    IT WAS REPORTED THAT THE SURGEON NOTICED A SCRATCH ON THE PRELOADED INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED IN THE RIGHT EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL AND DIOPTER). THERE WAS NO PATIENT INJURY. AN INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT IS DOING FINE. THE PRODUCT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 18092438 ↗
  • MalfunctionNov 19, 2021Material Fragmentation; Inaccurate Delivery; Material Fragmentation; Inaccurate Delivery

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD AN ISSUE WHERE THE BACK HAPTIC WAS RIPPED OFF FROM THE IOL DURING THE PRE-LOADED LENS DEPLOYMENT PROCESS. IT WAS NOTED THAT THE DAMAGED LENS WAS EXPLANTED FROM THE RIGHT EYE AND SUCCESSFULLY REPLACED WITH A BACK-UP IOL OF THE SAME MAKE AND POWER. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12842408 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

All LENS, INTRAOCULAR, TORIC OPTICS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.