BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2912972 · Received January 9, 2013

    Report

    Report Number
    3003701944-2013-00002
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 10, 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
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. DR. EZEQUIEL A. SALVO, ALEJANDRO D. COUSSIO, SPONTANEOUS EXTRUSION OF AN EX-PRESS VALVE: A CASE REPORT, REFRACTIVA; 2012;34: 9-11. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, A SURGEON REPORTED A CASE OF A SPONTANEOUS EXTRUSION OF A SHUNT FOLLOWING AN UNCOMPLICATED PHACOTRABECULECTOMY SURGERY. DURING SUBSEQUENT MONITORING, THE INTRAOCULAR PRESSURE (IOP) WAS NOTED TO BE INCREASED. MASSAGES AND NEEDLINS WERE PERFORMED, MEDICATIONS GIVEN AND THE IOP WAS STABILIZED. TWO AND A HALF MONTHS FOLLOWING THE INITIAL SURGERY, THE SHUNT WAS OBSERVED TO BE MORE SUPERFICIAL THROUGH THE SCLERAL FLAP. THE SHUNT THEN EXTRUDED TOWARD THE EXTERIOR THROUGH THE SCLERAL FLAP AND CONJUNCTIVA AND WAS REMOVED SEVEN MONTHS AFTER THE INITIAL SURGERY. A PERIPHERAL IRIDECTOMY WAS ALSO PERFORMED WITH A YAG LASER DAYS AFTER THE REMOVAL OF THE SHUNT. TO DATE, THE PATIENT HAS STABLE INTRAOCULAR PRESSURE (IOP) AND IS BEING TREATED WITH ANTI-GLAUCOMATOUS DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13169 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD. P-50 PL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention DUOTRAV| GLAUCOTENSIL TD| IOL