BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2040520 · Received March 18, 2011

    Report

    Report Number
    3003701944-2011-00008
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    January 12, 2011
    Manufacturer
    OPTONOL, LTD.
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/18/2011. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE SHUNT WOULD NOT EJECT FROM THE INJECTOR. PT IMPACT REMAINS UNK. ADDITIONAL 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1