BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 22386930 · Received July 2, 2025

    Report

    Report Number
    3012236936-2025-000182
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    November 6, 2024
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474812444
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3B: UNKNOWN; INFORMATION NOT PROVIDED. SECTION E1: TITLE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT SECTION G4: PMA/510(K) NUMBER IN THE INITIAL MDR WAS INADVERTENTLY SUBMITTED MISSING THE ¿P¿ BEFORE THE NUMERICAL VALUE. THE COMPLETE NUMBER IS P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT CATARACT SURGERY WITH A TECNIS ODYSSEY INTRAOCULAR LENS (IOL) ON (B)(6) 2024. AFTER THE SURGERY, THE SURGEON STATED THAT THE LENS WAS DEFECTIVE. ON (B)(6) 2025, THE PATIENT UNDERWENT A SECONDARY SURGICAL INTERVENTION FOR AN INTRAOCULAR LENS EXCHANGE IN THE LEFT EYE. DURING THIS PROCEDURE, THE ORIGINAL LENS WAS REMOVED AND REPLACED WITH AN EYHANCE TORIC LENS. THE PATIENT¿S POST-OPERATIVE CONDITION WAS REPORTED AS EXCELLENT, WITH NO COMPLICATIONS SUCH AS CAPSULAR TEARS NOTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10379 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT300 05050474812444

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention