BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 7485909 · Received May 4, 2018

    Report

    Report Number
    3006695864-2018-01008
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    March 28, 2018
    Report Date
    June 25, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HQC
    UDI-DI
    05050474534476
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INCORRECT AS IT SHOULD HAVE INDICATE THE YEAR 2014. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 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 & 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 THE ANTERIOR CHAMBER WAS LOST AND A VITRECTOMY PROCEDURE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328433 WHITESTAR SIGNATURE SYSTEM PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC NGP680300 05050474534476

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention