BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2529565 · Received April 5, 2012

    Report

    Report Number
    3003701944-2012-00024
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    January 1, 2011
    Report Date
    March 6, 2012
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 03/08/2012 BY FAX AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED IN A FOLLOW UP PHONE CALL ON 03/12/2012 AND 03/14/2012. MEDICAL RECORDS WERE RECEIVED ON 03/14/2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGERY COORDINATOR REPORTED THAT FIVE YEARS FOLLOWING INSERTION OF GLAUCOMA SHUNT, IT WAS REPOSITIONED IN THE EYE. THE REPORTER STATED THAT A NEW TRABECULECTOMY SITE WAS CREATED AND THE SHUNT WAS MOVED FROM THE ORIGINAL IMPLANTATION SITE TO ANOTHER SITE IN THE EYE. THE FELLOW EYE¿S SHUNT HAS PREVIOUSLY BEEN REPORTED UNDER MANUFACTURER REPORT # 3003701944-2012-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD R-50 PL 4902064

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention GLAUCOMA DROPS