BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITAS VISION SYSTEM

    MDR report key: 15556435 · Received October 6, 2022

    Report

    Report Number
    3012236936-2022-02515
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 8, 2022
    Report Date
    October 6, 2022
    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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AFTER THE SURGERY, CUSTOMER TESTED PRIMING WITH OPO73, AND IT PASSED WITHOUT ANY ISSUE. DEVICE EVALUATION: A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, 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 ERRORS OCCURRED DURING ULTRASONIC, WAS OSCILLATED WHEN MODE WAS CHANGED FROM DIA TO PHACO 1. THE ERRORS WERE 160 (GFI PRESSURE IS TOO LOW) AND 161(GFI PRESSURE IS TOO HIGH). VRT-AI (VERITAS ADVANCED INFUSION PACK) WAS REPORTEDLY NOT REUSED FOR MULTIPLE PATIENTS. CUSTOMER REPLACED TUBING PACK; HOWEVER, THE ISSUE WAS NOT RESOLVED. CUSTOMER DID NOT REBOOT THE MACHINE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BACKUP MACHINE. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN THE PROBLEM WAS CAUSED BY VRT-AI OR VERITAS CONSOLE. THIS EVENT WILL CAPTURE INFORMATION FOR VERITAS CONSOLE. A SEPARATE MDR IS BEING SUBMITTED FOR VRT-AI. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855828 VERITAS VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT680300 05050474700864

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MODEL: VRT-AI LOT: UNKNOWN