BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 4925413 · Received July 20, 2015

    Report

    Report Number
    3003701944-2015-00601
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    January 27, 2015
    Report Date
    July 29, 2015
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND 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. TREND AND LOT REVIEW WERE PERFORMED, NO UNFAVORABLE TRENDS WERE IDENTIFIED. ALTHOUGH 4 PREVIOUS COMPLAINTS WERE FOUND FOR THE LOT, THOSE PREVIOUS COMPLAINTS HAVE DIFFERENT EVENT CODES WHICH ARE UNRELATED TO CURRENT COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT SURGERY, A PATIENT EXPERIENCED A FOREIGN BODY SENSATION. UPON EXAMINATION, THE GFD WAS FOUND TO BE PARTLY EXPOSED UNDER THE CONJUNCTIVA WHERE A PART OF THE SCLERAL FLAP WAS MISSING. THE GFD WAS EXPLANTED AS A PRECAUTION FOR INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IN A FOLLOW UP, THE SURGEON INDICATED THAT HE SUSPECTS THE SHUNT IMPLANTATION SURGERY WAS A FACTOR OF CONJUNCTIVA AND SCLERAL DAMAGE CAUSING THE SHUNT TO BECOME EXPOSED. HE ALSO INDICATED THAT THE USE OF A METABOLIC INHIBITOR MAY HAVE CONTRIBUTED AS WELL. PATIENT SYMPTOMS RESOLVED ONE WEEK AFTER SHUNT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468545 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 132706

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention