BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3881083 · Received April 9, 2014

    Report

    Report Number
    3003701944-2014-00047
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    May 17, 2013
    Report Date
    July 25, 2017
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE SHUNT REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    IN A FOLLOW UP, THE SURGEON CLARIFIED THAT THE SHUNT WAS IN CONTACT WITH THE CORNEA 18 TO 24 MONTHS AFTER INITIAL IMPLANTATION. HE ALSO REPORTED THAT THE EYE WAS HYPOTENOUS FOR ONE WEEK AFTER THE SHUNT WAS IMPLANTED. AT THE 18 MONTH POSTOPERATIVE VISIT, THE INTRAOCULAR PRESSURE (IOP) WAS INCREASED AND THREE GLAUCOMA EYE DROP MEDICATIONS WERE PRESCRIBED. THE SURGEON OPTED TO EXPLANT THE SHUNT AND DO A TRABECULECTOMY ON (B)(6) 2014. THE PATIENT WAS LISTED AS RECOVERING THE FOLLOWING MONTH.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING AN IMPLANT OF A GLAUCOMA FILTRATION DEVICE (GFD), THE TIP OF THE GFD TOUCHED THE CORNEA. ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IN A FOLLOW UP, THE SURGEON EXPLAINED THAT BOTH THE MAIN PORT AND THE SIDE PORT OF THE SHUNT WERE BLOCKED BY THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213385 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 123039

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention