BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3234025 · Received July 16, 2013

    Report

    Report Number
    3003701944-2013-00059
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 18, 2013
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED ND VISUAL INSPECTION CANNOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) FOR THE BATCH WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THREE MONTHS FOLLOWING A GLAUCOMA FILTRATION SHUNT PROCEDURE, THE PT HAD OCULAR HYPERTENSION. THE SURGEON REPORTED THAT A MASSAGE, DRUG TREATMENT, AND AN OUTFLOW RECONSTRUCTION SURGERY WERE PERFORMED. ONE MONTH FOLLOWING THE FIRST RECONSTRUCTION SURGERY, OCULAR HYPERTENSION WAS OBSERVED AND A SECOND RECONSTRUCTION SURGERY WAS REQUIRED. THE INTRAOCULAR PRESSURE (IOP) CONTINUED TO INCREASE ONE WEEK FOLLOWING THE SECOND SURGERY. THE SHUNT WAS EXPLANTED AND A THIRD RECONSTRUCTION SURGERY WAS PERFORMED. THE SURGEON REPORTED THE REASON FOR USING THE SHUNT WAS THAT THE RESULTS FROM THE PRIOR GLAUCOMA SURGERY WERE NOT GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328261 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 121103

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention XALATANE| ALPHAGUN| LUMINGAN| DIAMOX| COSOPT