BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 24186195 · Received January 27, 2026

    Report

    Report Number
    3012236936-2026-000027
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 12, 2026
    Report Date
    January 27, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474812048
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS BROKEN. THE PRODUCT CONTACTED THE EYE. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, SUTURES, OR MEDICATION OUTSIDE THE STANDARD OF CARE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248548 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT225 05050474812048

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female