BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO

    MDR report key: 11602089 · Received April 1, 2021

    Report

    Report Number
    3006695864-2021-07415
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 9, 2021
    Report Date
    May 6, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    UDI-DI
    05050474596146
    PMA / PMN Number
    K151636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. ALL MODES OF OPERATION AND CALIBRATIONS WERE VERIFIED, AND NO FAILURES WERE DETECTED. THE UNIT COMPLIED WITH ALL FACTORY SETTINGS. 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 WHITESTAR SIGNATURE PRO SYSTEM (S/N#: (B)(6)) 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    TELEPHONE: (B)(6). MANUFACTURER YEAR 2017. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING A CATARACT PROCEDURE, IT WAS REPORTED A CAPSULE TEAR OCCURRED RESULTING IN A VITRECTOMY PROCEDURE WHEN USING THE SIGNATURE PRO PHACOEMULSIFICATION UNIT. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. A DESCRIPTION OF THE EVENT IS THAT THE SIGNATURE PRO HAD VACUUM PERFORMANCE ISSUES DURING THE PROCEDURE AND THERE ARE NUMBER OF PATIENTS THAT EXPERIENCE CHAMBER INSTABILITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499680 WHITESTAR SIGNATURE PRO UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC NGP680301 05050474596146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention