BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO CONSOLE

    MDR report key: 8933574 · Received August 26, 2019

    Report

    Report Number
    3006695864-2019-00697
    Event Type
    Injury
    Date Received
    August 26, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474596146
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE IS UNKNOWN / NOT PROVIDED, BEST ESTIMATED DATE IS (B)(6) 2019. DEVICE MANUFACTURE DATE: YEAR 2017. THE SYSTEM WAS EVALUATED BY A JOHNSON & JOHNSON PHACO SPECIALIST VISITED THE ACCOUNT. THE SPECIALIST PROVIDED SURGERY SUPPORT AND VERIFIED SURGEON SETTINGS. THERE WERE NO ISSUES OBSERVED AND ALL CASES OBSERVED WERE COMPLETELY SUCCESSFULLY. 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL: IN INITIAL REPORT, THE MANUFACTURER YEAR WAS ONLY PROVIDED, HOWEVER THE FULL DATE IS 08/01/2017. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED A CAPSULAR TEAR RESULTING IN A VITRECTOMY SURGICAL PROCEDURE. THE SURGERY CENTER INDICATED THERE WAS A SMALL TEAR IN THE CAPSULE BAG DURING THE IRRIGATION / ASPIRATION CORTEX SEGMENT. THE SURGEON INDICATED HAS BEEN USING THE SAME SETTINGS AND SAME MODEL FOR YEARS WITHOUT INCIDENT, HOWEVER, WAS NOT SURE WHAT CAUSED THE EVENT AND FELT IT MAY HAVE BEEN PATIENT RELATED. THIS IS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727163 WHITESTAR SIGNATURE PRO CONSOLE PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC. NGP680301 05050474596146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention