BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 22546051 · Received July 18, 2025

    Report

    Report Number
    3012236936-2025-000198
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 23, 2025
    Report Date
    January 8, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811577
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME SURGERY. 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 THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN RECEIVED. 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. THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION G4: PMA/510(K) NUMBER: P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE WITH A TORIC INTRAOCULAR LENS (IOL), THE LENS WAS DESCRIBED AS DIFFICULT TO ADVANCE AND WAS OBSERVED TO BE CRACKED UPON IMPLANTATION. CONSEQUENTLY, THE LENS WAS REMOVED AFTER BEING CUT. A BACKUP LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED IN ITS PLACE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395642 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown