BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2754637 · Received September 20, 2012

    Report

    Report Number
    3003701944-2012-00053
    Event Type
    Injury
    Date Received
    September 20, 2012
    Date of Event
    January 1, 2011
    Report Date
    August 21, 2012
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NO ROOT CAUSE COULD BE DETERMINED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. AHMED, Y., PATHENGAY, A., FLYNN, H.F., ISON, R. (2012). DELAYED-ONSET ENDOPHTHALMITIS ASSOCIATED WITH EX-PRESS MINI GLAUCOMA SHUNT. OPHTHALMIC SURGERY, LASERS & IMAGING, 43, 62-63. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE A SURGEON REPORTED A PT WHO WAS DIAGNOSED WITH DELAYED-ONSET ENDOPHTHALMITIS SECONDARY TO BACILLUS SP. IN HIS LEFT EYE THREE YEARS FOLLOWING GLAUCOMA FILTRATION SURGERY. THE PT PRESENTED WITH PAIN, REDNESS, DECREASED VISION, 3+ CONJUNCTIVAL INJECTION, EDEMA AND A HAZY CORNEA. THE ANTERIOR CHAMBER WAS FORMED AND HAD 2-MM HYPOPYON AND MODERATE FIBRIN. FIBRIN ON THE INTRAOCULAR LENS AND VITREOUS CELLS OBSCURED VISUALIZATION OF THE RETINA. FOLLOWING DIAGNOSIS OF ENDOPHTHALMITIS ASSOCIATED WITH THE SHUNT THE PT UNDERWENT A VITREOUS TAP FOLLOWED BY INTRAVITREAL INJECTIONS. FOLLOWING TREATMENT, PAIN DECREASED AND THE FIBRIN ON HIS INTRAOCULAR LENS STARTED CONTRACTING WITH RESOLUTION OF HYPOPYON. AT THE 1-MONTH FOLLOW-UP VISIT, VISUAL ACUITY WAS 3/200 WITH RESOLUTION OF FIBRIN AND HYPOPYON IN THE ANTERIOR CHAMBER. IT WAS NOTED THAT THE POOR VISION WAS DUE TO NEAR TOTAL CUPPING OF THE OPTIC NERVE HEAD. THE PT REFUSED SURGERY TO REVISE OR REMOVE THE SHUNT. ADDITIONAL INFORMATION 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 92 YR Required Intervention BAERVELDT IMPLANT