BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2003653 · Received February 24, 2011

    Report

    Report Number
    3003701944-2011-00002
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    OPTONOL, LTD.
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS INDICATED FOR THIS COMPLAINT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) FOR THE LOT COULD NOT BE REVIEWED FOR ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONAL INFO WAS REQUESTED BY FAX AND MAIL ION 01/27/2011 AND BY PHONE ON 02/17/2011. CITATION: STEWART, R.M., DIAMOND, J.G., ASHMORE, E.D., AYYALA, R.S. (2005) COMPLICATIONS FOLLOWING EX-PRESS GLAUCOMA SHUNT IMPLANTATION. AMERICAN JOURNAL OF OPHTHALMOLOGY 2005; 140:000-000, ELSEVIER, INC. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 02/24/2011. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED A LITERATURE ARTICLE, "COMPLICATIONS FOLLOWING EX-PRESS GLAUCOMA SHUNT IMPLANTATION", PUBLISHED IN THE AMERICAN JOURNAL OF OPHTHALMOLOGY IN 2005 (ELSEVIER INC, 002-9394/05) A PT (CASE 1) WITH OPEN-ANGLE GLAUCOMA HAD A SHUNT INSERTED IN THE LEFT EYE. THE PT WAS REFERRED THREE MONTHS LATER WITH POSTOPERATIVE INCREASED INTRAOCULAR PRESSURE (IOP) OF 34 MM HG. THE PT WAS ON MAXIMUM MEDICATIONS RESULTING FROM SUBCONJUNCTIVAL FIBROSIS. A TRABECULECTOMY WITH MITOMYCIN C WAS PERFORMED IN THE SUPRANASAL QUADRANT AND SIX MONTHS LATER IOP WAS 12 MM HG. THE SHUNT REMAINS IMPLANTED. THIS MDR IS #1 OF 4 RELATED MDRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention