BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2032413 · Received March 25, 2011

    Report

    Report Number
    3003701944-2011-00010
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 25, 2011
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 OPTONOL'S ACCEPTANCE CRITERIA. ADD'L INFO WAS REQUESTED ON (B)(4) 2011 AND (B)(4) 2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/25/2011. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED SHE CONVERTED TO A TRABECULECTOMY WHEN THE SHUNT FAILED TO GO THROUGH THE CORNEA DURING IMPLANT SURGERY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 102818

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention