BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS VISION SYSTEM

    MDR report key: 15655594 · Received October 21, 2022

    Report

    Report Number
    3012236936-2022-02629
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 23, 2022
    Report Date
    October 21, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474700864
    PMA / PMN Number
    K203060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION AGE OR DATE OF BIRTH, WEIGHT, ETHNICITY: INFORMATION WAS REQUESTED TO THE ACCOUNT. HOWEVER, AT THE TIME OF THIS REPORT, THEY HAVE NOT PROVIDED IT. A REQUEST FOR PATIENT DEMOGRAPHICS AND PATIENT OUTCOME WAS REQUESTED. NO ADDITIONAL INFORMATION WAS RECEIVED. DEVICE EVALUATION: THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER (FSE). THE FSE WAS ONSITE DUE TO SYSTEM ADVANCING MODES WITHOUT THE FOOTPEDAL (FP) BEING ACTIVATED. THE FSE COULD NOT DUPLICATE REPORTED ISSUE. SERVICE COMPLETED VERITAS PERFORMANCE CHECKLIST AND REPLACED THE (FP) PROACTIVELY. THE VERITAS SYSTEM MEETS JNJ SPECIFICATIONS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR VERITAS SSTEM SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, NO CORRECTIVE ACTION HAS BEEN ISSUED. CONCLUSION: A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED; THEREFORE, NO ADDITIONAL CORRECTIVE ACTIONS HAVE BEEN INITIATED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE ACCOUNT REPORTED SYSTEM ADVANCED MODES WITHOUT THE SURGEON ACTIVATING FOOT SWITCH. THE SURGEON WAS OPERATING AND WAS IN THE EPI SETTING WHEN THE MACHINE ADVANCED TO THE IA CORTEX MODE WITHOUT HIM ACTIVATING IT MANUALLY WITH THE FOOT SWITCH. IT HAPPENED MULTIPLE TIMES BUT ONLY ONCE DID HE HAVE PATIENT INJURY RESULTING IN A VITRECTOMY. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT IS FOR THE VERITAS CONSOLE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2463070 VERITAS VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. VRT680300 05050474700864

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention VERITAS FOOT PEDAL S/N (B)(4).