BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO CONSOLE

    MDR report key: 9455741 · Received December 11, 2019

    Report

    Report Number
    3006695864-2019-00977
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    November 14, 2019
    Report Date
    November 4, 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
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED. ALL SECTIONS OF THIS FOLLOW UP REPORT HAVE BEEN UPDATED ACCORDINGLY. FEMALE REQUIRED INTERVENTION THE CAPSULAR LENS DAMAGE REPORTED WAS A BROKEN CAPSULE THAT REQUIRED A VITRECTOMY ON THE RIGHT OPERATIVE EYE. AN INCISION ENLARGEMENT WAS PERFORMED, AND THE INTRAOCULAR LENS WAS IMPLANTED ON THE SULCUS. THE PROCEDURE WAS COMPLETED. THE PATIENT OUTCOME IS SATISFACTORY. DR AUGUST PARDO HEALTH PROFESSIONAL: YES PHYSICIAN PATIENT CODE 2639 FOR CAPSULAR TEAR PATIENT CODE 2643 FOR VITRECTOMY ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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.

    Description of Event or Problem · 0

    A BROKEN CAPSULE THAT REQUIRED A VITRECTOMY ON THE RIGHT OPERATIVE EYE. AN INCISION ENLARGEMENT WAS PERFORMED, AND THE INTRAOCULAR LENS WAS IMPLANTED ON THE SULCUS. THE PROCEDURE WAS COMPLETED. THE PATIENT OUTCOME IS SATISFACTORY.

    Additional Manufacturer Narrative · 1

    IN INITIAL REPORT, THE MANUFACTURER YEAR WAS ONLY PROVIDED HOWEVER THE FULL DATE IS PROVIDED IN THIS FOLLOW UP REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    REPORTER TELEPHONE: UNKNOWN AS IT WAS NOT PROVIDED. MANUFACTURER YEAR 2017. (B)(4). THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE FOUND NO ISSUES WITH THE UNIT. A FIELD SERVICE CHECKLIST WAS PERFORMED. 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 PROCEDURE, IT WAS REPORTED THERE WAS CAPSULAR LENS DAMAGE DURING THE LAST SURGERY OF THE DAY WHEN USING THE SIGNATURE PRO CONSOLE. ALTHOUGH, THERE WERE SEVERAL ATTEMPTS TO FOLLOW UP WITH THE SURGERY CENTER, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249634 WHITESTAR SIGNATURE PRO CONSOLE PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC. NGP680301 05050474596146

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R