BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO CONSOLE

    MDR report key: 8669091 · Received June 4, 2019

    Report

    Report Number
    3006695864-2019-00451
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 10, 2019
    Report Date
    November 12, 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
    NY, 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

    MANUFACTURER YEAR 2019 THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE FOUND NO ISSUES WITH THE UNIT, HANDPIECE, TIP, AND TUBING CASSETTE. A FIELD SERVICE CHECKLIST WAS PERFORMED. ALL MODES OF OPERATION AND CALIBRATIONS WERE VERIFIED. 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.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INITIAL REPORT ONLY THE MANUFACTURING YEAR 2019 WAS REPORTED. HOWEVER, DHR REVIEW REVEALED THE FULL DATE OF MANUFACTURE WAS 01/07/2019. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE, A CORNEAL BURN OCCURRED IN THE PATIENT¿S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461007 WHITESTAR SIGNATURE PRO CONSOLE PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC. NGP680301 05050474596146

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HANDPIECE & TIP, TUBING PACK