BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 17159867 · Received June 19, 2023

    Report

    Report Number
    3012236936-2023-01426
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 19, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474709911
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON EXPERIENCED A FAILURE OF IMPLANTATION WITH A PRELOADED INTRAOCULAR LENS (IOL). THE SURGEON IS A LONGTIME USER AND HAS NOT HAD ANY ISSUES USING THE DEVICES. ACCOUNT INDICATED THAT THE PRELOADED IOL DEVICE WAS PLACED IN THE OVEN PROVIDED BY PHYSIOLS FOR SOME TIME, TEMPERATURE NOT EXCEEDING 37 DEGREES CELSIUS. THE INJECTOR WAS DAMAGED; HOWEVER, THE DAMAGED TIP OF THE INJECTOR WAS SUCCESSFULLY USED TO IMPLANT THE LENS WITHOUT ANY HARM TO THE PATIENT. THE IOL REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014052 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V 05050474709911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown