BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE 23GA VITRECTOMY CUTTER

    MDR report key: 20397940 · Received October 8, 2024

    Report

    Report Number
    3012236936-2024-000270
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 11, 2024
    Report Date
    January 21, 2025
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MLZ
    UDI-DI
    05050474534100
    PMA / PMN Number
    K081681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS DOWNGRADED AND IS NO LONGER CONSIDERED REPORTABLE SINCE THE VITRECTOR WAS FOUND NOT TO BE THE CAUSE OF THE POSTERIOR CAPSULE TEAR. OUR SUBJECT MATTER EXPERT CONCLUDED THAT THE COMPLAINT INVOLVING THE VITRECTOR HAPPENED ONLY AFTER THE TEAR HAD ALREADY OCCURRED. NO ADDITIONAL DETAILS WILL BE GIVEN REGARDING THIS CASE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    . THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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, 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

    CUSTOMER HAD AN ISSUE WITH THE VITRECTOR, IT DID NOT CUT OR WAS NOT WORKING PROPERLY. PHYSICIAN WAS TRYING TO REMOVE THE CORTEX FROM THE CAPSULE BAG BECAUSE THERE WAS A SLIGHT TEAR. THE VITRECTOR WOULD NOT ASPIRATE OR CUT. THEY DID NOT USE A NEW ONE. PHYSICIAN DECIDED TO JUST INSERT THE LENS AND MOVE ON WITH REMAINING CORTEX. CASE WAS COMPLETED WITH NO PATIENT ADVERSE EFFECTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718069 DISPOSABLE 23GA VITRECTOMY CUTTER VITRECTOMY, INSTRUMENT CUTTER MLZ JOHNSON & JOHNSON SURGICAL VISION, INC. NGP0023 60428266 05050474534100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other