BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ODYSSEY TORIC II IOL

    MDR report key: 23992219 · Received January 7, 2026

    Report

    Report Number
    3012236936-2026-000011
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    October 29, 2025
    Report Date
    January 7, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474811126
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6, PATIENT INFORMATION: DECLINED DUE TO PATIENT PRIVACY. 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. AN ATTEMPT WAS 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 JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE. THE PATIENT WAS NOT PLEASED WITH THE LENS IN HIS SECOND EYE, ALTHOUGH HE WAS SATISFIED WITH THE FIRST EYE WHICH HAS AN ODYSSEY TORIC LENS. THE PATIENT¿S DISSATISFACTION WAS NOTED IN THEIR OFFICE VISIT ONE DAY POST-OPERATIVELY. CONSEQUENTLY, THIS IOL (SECOND EYE) WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS MODEL ZCU150 9.0 DIOPTER. THERE WAS NO CAPSULE TEAR, VITRECTOMY, SUTURES OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58840 TECNIS ODYSSEY TORIC II IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRT150 05050474811126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention