BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 3920345 · Received July 8, 2014

    Report

    Report Number
    2020664-2014-00053
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN INITIAL REPORT, THE CATEGORY FOR OUTCOMES ATTRIBUTED TO ADVERSE EVENT WAS NOT COMPLETED AS THE SELECTION SHOULD HAVE BEEN REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THIS FOLLOW UP HAS SELECTION CHECKED. CORRECTION: IN INITIAL REPORT, DATE RECEIVED BY MANUFACTURER WAS NOT PROVIDED. IT SHOULD HAVE INDICATED 6/11/2014 CORRECTION: IN FOLLOW-UP 1, DATE RECEIVED BY MANUFACTURER WAS NOT PROVIDED. IT SHOULD HAVE INDICATED 8/27/2014 ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. THROUGH FOLLOW UP, THE CLINIC INDICATED THE SURGEON DID NOT BELIEVE THE REPORTED EVENT WAS CAUSED BY THE AMO EQUIPMENT AND BELIEVED THE SURGEON SETTINGS REQUIRED ADJUSTMENT TO CONTROL THE FLOW OF MODES WHEN IN USE. AN AMO PHACO SPECIALIST VISITED THE SITE AND MODIFIED SURGEON SETTINGS INCLUDING VITRECTOMY MODE. IN ADDITION, THE CUSTOMER INDICATED THE CLINIC'S BIOMEDICAL DEPARTMENT CHECKED AND TESTED THE UNIT AND FOUND NO ISSUES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN 3006695864. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE THE CLINIC REPORTED A POSTERIOR CAPSULAR TEAR IN THE OPERATIVE EYE. THE CLINIC INDICATED THE IRRIGATION FLOW FROM THE VITRECTOMY HANDPIECE WAS POOR; CONSEQUENTLY THE CHAMBER BECAME SHALLOW. THE POSTERIOR CAPSULE REQUIRED THE INCISION TO BE ENLARGED AND A VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397978 WHITESTAR SIGNATURE SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention