BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO CONSOLE

    MDR report key: 8258939 · Received January 17, 2019

    Report

    Report Number
    3006695864-2019-00032
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 20, 2018
    Report Date
    November 6, 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
    CA
    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

    ADDITIONAL: IN INITIAL REPORT, THE MANUFACTURER YEAR WAS PROVIDED ONLY. ADDITIONAL INFORMATION WAS PROVIDED THAT THE MONTH OF OCTOBER WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURER YEAR 2016. THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE FOUND NO ISSUES WITH THE UNIT. 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.

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE, A CORNEAL BURN OCCURRED IN THE PATIENT¿S OPERATIVE EYE WHEN USING THE WHITESTAR SIGNATURE PRO CONSOLE AND SIGNATURE DUAL PUMP PACK, MODEL OPO73. THE CORNEAL BURN OCCURRED DURING SCULPT MODE ON A VERY DENSE HARD CATARACT CASE. THE SURGERY CENTER INDICATED THE IRRIGATION SEGMENT SEEMED A LITTLE SLOW DURING THE CASE. THE SURGEON INDICATED THE CORNEAL BURN MAY HAVE BEEN RELATED TO THE VERY DENSE CATARACT BUT WAS NOT SURE. A SUTURE WAS REQUIRED TO CLOSE THE WOUND. THIS REPORT IS FOR THE PHACOFRAGMENTATION CONSOLE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE TUBING PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50091 WHITESTAR SIGNATURE PRO CONSOLE PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC NGP680301 05050474596146

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention TUBING PACK OPO73 LOT NO. 60146533