BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITAS VISION SYSTEM

    MDR report key: 13122260 · Received December 30, 2021

    Report

    Report Number
    3012236936-2021-00385
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 8, 2021
    Report Date
    February 3, 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
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H4 - MANUFACTURING DATE - THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS 9/24/2021. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: FIELD SERVICE AGENT TESTED THE SYSTEM AND WAS NOT ABLE TO DUPLICATE REPORTED ISSUE BUT DID SEE ERRORS IN EVENT LOG. VERITAS CHECKLIST AND SYSTEM CHECKS USING STANDARD SETTING WERE PERFORMED AND NO PROBLEM WAS FOUND. VERITAS MEETS SPECIFICATION. MANUFACTURING RECORD REVIEW: 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. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHACO MACHINE GAVE160 ERROR DURING PRIME AND DURING QUADRANT. THE 160 ERROR REFERS TO ADVANCED INFUSION PRESSURE IS LOW. THE ERROR WAS OBSERVED TWICE ONE DURING PRIMING AND ANOTHER DURING THE PHACO PROCEDURE. THERE WAS NO PATIENT INJURY AND NO REPORTED SURGICAL INTERVENTION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020538 VERITAS VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT680300 05050474700864

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown