BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 17666805 · Received August 31, 2023

    Report

    Report Number
    3012236936-2023-02214
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 28, 2023
    Report Date
    August 31, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474747050
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A5 (ETHNICITY): UNKNOWN/ NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION H3:81 - OTHER: THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED BY THE ACCOUNT; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FAULTY INSERTER IN A PRELOADED PRODUCT, BACK HAPTIC WAS SEVERED FROM THE LENS. THE LENS WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE. MICROSURGICAL TECHNOLOGY (MST) SET USED FOR REMOVAL OF THE LENS. THE LENS WAS REPLACED WITH THE BACK-UP LENS SAME MODEL, SAME DIOPTER POWER SIZE LENS. THERE WAS NO PATIENT POST-OP INJURY. THE SUSPECT PRODUCT IS NOT BEING RETURNED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190096 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU225 05050474747050

    Patients

    Seq Age Sex Outcome Treatment
    1 Female