BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT INTUITIV CONSOLE

    MDR report key: 10527888 · Received September 14, 2020

    Report

    Report Number
    3006695864-2020-00430
    Event Type
    Injury
    Date Received
    September 14, 2020
    Report Date
    September 14, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474573628
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. THE JOHNSON AND JOHNSON REPRESENTATIVE PROVIDED THAT NO FURTHER STEPS WERE REQUESTED. THE DOCTOR WAS PRIMARILY LOOKING FOR THE MANUFACTURER TO PROVIDE A SAFER ABILITY TO SEE WHICH SYSTEM SETTINGS WERE ON DURING PHACO. THIS ISSUE HAS BEEN REFERRED TO MEDICAL AFFAIRS FOR MEDICAL REVIEW DUE TO PATIENT SAFETY CONCERNS AND TO DESIGN ENGINEERING FOR EVALUATION OF POTENTIAL FUTURE PRODUCT ENHANCEMENTS. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE PHACO SYSTEM (COMPACT INTUITIV CONSOLE) 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. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    A SURGERY CENTER REPORTED A POSSIBLE MILD CORNEAL BURN DURING A PHACO SESSION. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME. THE SITE PERFORMED THEIR OWN INVESTIGATION WHICH REVEALED THAT THE PHACO SYSTEM SETTINGS HAD BEEN INADVERTENTLY CHANGED FROM THEIR NORMAL 33% AT 6MS ON 12MS OFF TO A SETTING WITH 60% ON TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996236 COMPACT INTUITIV CONSOLE COMPACT INTUITIV HQC JOHNSON & JOHNSON SURGICAL VISION, INC. SCP680300 05050474573628

    Patients

    Seq Age Sex Outcome Treatment
    1