BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO CONSOLE

    MDR report key: 7572359 · Received June 6, 2018

    Report

    Report Number
    3006695864-2018-01305
    Event Type
    Injury
    Date Received
    June 6, 2018
    Report Date
    July 2, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HQC
    UDI-DI
    05050474596146
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    CORRECTION: IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INCORRECT AS IT SHOULD HAVE INDICATE THE 08/2017. 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 BROKEN POSTERIOR CAPSULE. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THERE WAS BREAKAGE OF THE POSTERIOR CAPSULE AND THE NUCLEAR FELL. THE SURGEON REPORTED THE EVENT OCCURRED DUE TO THE DEFAULT SETTINGS WERE INADVERTENTLY SELECTED INSTEAD OF THE SURGEON¿S SETTINGS. THE DEFAULT VACUUM SETTINGS WERE PROGRAMMED AT THE VALUE OF 300 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418268 WHITESTAR SIGNATURE PRO CONSOLE PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC NGP680301 05050474596146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention