BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2792218 · Received October 12, 2012

    Report

    Report Number
    3003701944-2012-00061
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    January 1, 2011
    Report Date
    September 12, 2012
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 WAS REQUESTED ON 09/14/2012 AND 09/21/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED, THE SHUNT EXTRUDED AND CAME INTO CONTACT WITH THE IRIS. THERE WAS NO DAMAGE TO THE EYE OR IRIS BUT "SOME TYPE OF CORRECTED PROCEDURE" WAS REQUIRED. THE SURGEON REPORTED THE EVENT OCCURRED ABOUT ONE YR AGO. 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 UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention