BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23746609 · Received December 8, 2025

    Report

    Report Number
    3012236936-2025-000326
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    October 29, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474825857
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: UNKNOWN/ NOT PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: 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 RECORDS INCLUDING DEVICE HISTORY AND 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IOL WAS EXPLANTED DUE TO PATIENT NEUROADAPTATION. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2754970 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT100 05050474825857

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention