BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITAS VISION SYSTEM

    MDR report key: 17099118 · Received June 9, 2023

    Report

    Report Number
    3012236936-2023-01320
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 9, 2023
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474700864
    PMA / PMN Number
    K203060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    501

    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 E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE VERITAS CONSOLE HAS NOT YET BEEN EVALUATED. 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 INITIALLY REPORTED THAT THE VERITAS CONSOLE SHOWED A REPETITIVE ERROR #161: GFI PRESSURE TOO HIGH DURING SURGERY. THE SURGEON HAD TO STOP THE SURGERY AND RESTART THE MACHINE WITH A NEW PRIME/TUNE CYCLE AND DEACTIVATE THE ADVANCED INFUSION FEATURE. THE ERROR OCCURRED DURING SURGERY AND INTERRUPTED THE PROCEDURE FOR A MINUTE. THERE WERE NO INTERVENTIONS REQUIRED AND THE EQUIPMENT HAD TO BE RESTARTED. THROUGH FOLLOW-UP WE LEARNED THAT AFTER SURGERY THE JOHNSON AND JOHNSON SPECIALIST FOR PHACOEMULSIFICATION EQUIPMENT HAD TO DISABLE THE ADVANCED INFUSION AND PURGE AND TUNE THE EQUIPMENT DUE TO THE ERROR. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452078 VERITAS VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT680300 05050474700864

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown