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TECNIS IOL DIU300 (REF DIU300U200)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 20.0D CYL3.00 · Class 3 · Implant

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474747722), received between Mar 15, 2024 and Jul 11, 2025 — classified as 2 injuries.

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: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 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: 1 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

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Eye Injury1
  • No Clinical Signs, Symptoms or Conditions1
  • Vitreous Loss1

Recent adverse event reports

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

  • InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY THE CUSTOMER THAT A SURGEON IS PERFORMING A LENS EXCHANGE ON A PATIENT, WHERE THE ORIGINAL LENS WAS IMPLANTED BY ANOTHER SURGEON. ADDITIONAL INFORMATION SUGGESTS THE LENS WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

    MAUDE report 22487029 ↗
  • InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE DIU300 MODEL INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED AND REMOVED DURING THE SAME PROCEDURE DUE TO VITREOUS IN THE ANTERIOR CHAMBER. THE INCISION WAS ENLARGED, SUTURE(S) AND VITRECTOMY WERE REQUIRED. THE PROCEDURE WAS COMPLETED USING A NON-JOHNSON & JOHNSON SURGICAL VISION SULCUS LENS THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). A PATIENT ANATOMY ISSUE WAS ATTRIBUTED TO THE REPORTED EVENT AND NOT A PRODUCT QUALITY ISSUE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS CUSTOMER UNAWARE OF ANY ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

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

    MAUDE report 18913794 ↗

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.