BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 8337802 · Received February 13, 2019

    Report

    Report Number
    3006695864-2019-00123
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    January 23, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474534476
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 · 0

    IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS 7/18/2014, HOWEVER THE CORRECT DATE IS 04/17/2014. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. 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 THERMAL BURN OCCURRED IN THE PATIENT¿S OPERATIVE EYE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PRIME AND TUNE STAGE WAS SUCCESSFUL AND THE THERMAL BURN OCCURRED DURING PHACO MODE 1 AS HEAT GENERATED AS ASPIRATION WAS LOW. THE PATIENT¿S COMMENTS WERE THAT WHEN THE THERMAL BURN OCCURRED, THE PATIENT FELT HOT AT THE TIME. AS THE PROCEDURE CONTINUED, A CAPSULAR RUPTURE OCCURRED AND THE LENS THAT WAS PLACED, WAS TAKEN OUT. THE SURGERY CENTER INDICATED THERE WAS 4 TO 5 SUTURES PLACED TO CLOSE THE WOUND AND A VITRECTOMY PROCEDURE WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING A BACKUP. IT WAS ALSO STATED THE PATIENT REQUIRED HOSPITALIZATION FOR 2 DAYS. THE SURGERY CENTER SUSPECTS THE THERMAL BURN MAY HAVE BEEN CAUSED BY THE HANDPIECE HAVING A CLOG AND THE PASSAGE OF FLUIDS DID NOT FLOW BECAUSE THE VISCOELASTIC WAS USED IN A SITUATION WHERE IT COULD NOT SECURE THE SPACE THROUGH WHICH BALANCE SALT SOLUTION FLOWS. ALTHOUGH ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, IT IS UNKNOWN IF WHEN THE SURGERY CENTER STATES THE PROCEDURE WAS COMPLETED USING A BACKUP IF IT MEANS IT WAS A BACKUP PHACO CONSOLE OR A BACKUP HANDPIECE TO CONTINUE WITH THE PROCEDURE. IT IS ALSO UNKNOWN WHY THE PATIENT REQUIRED HOSPITALIZATION AND PATIENT OUTCOME. THIS REPORT IS FOR PHACOFRAGMENTATION UNIT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACO HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127772 WHITESTAR SIGNATURE SYSTEM PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC. NGP680300 05050474534476

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R PHACO HANDPIECE, HEALON V