BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 8465549 · Received March 29, 2019

    Report

    Report Number
    3003701944-2019-00012
    Event Type
    Injury
    Date Received
    March 29, 2019
    Report Date
    July 22, 2019
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT HE HAS REMOVED THE GFD FROM THE EYE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. NO ABNORMALITIES WERE FOUND, AND THE BATCH WAS RELEASED ACCORDING TO RELEASE CRITERIA. THERE WERE NO OTHER COMPLAINTS FOR THE LOT. THE SAMPLE IS NOT AVAILABLE FOR THE INVESTIGATION. DURING PRODUCTION, 100% FINAL INSPECTION IS PERFORMED ON THE ENTIRE BATCH, INCLUDING VISUAL INSPECTION AND INNER ILLUMINATION. IF A BLOCKAGE WOULD BE NOTICED, THE PRODUCT WOULD HAVE BEEN REJECTED IMMEDIATELY. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE, SINCE NO SAMPLE WAS RETURNED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT 10 YEARS FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, THE GFD HAS ERODED THROUGH THE SURFACE OF THE CONJUNCTIVA. THE SHUNT FAILED YEARS AGO. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT THE EFFECTS OF THIS GFD FAILED "YEARS AGO," LOSING BLEB FORMATION AND FILTERING ABILITY. THE CONJUNCTIVA OVERLYING THE DEVICE HAS RECENTLY ERODED WITH THE DEVICE NOW EXPOSED TO THE EXTERNAL ENVIRONMENT. THE SURGEON IS PROPHYLACTICALLY TREATING THIS EYE WITH TOPICAL ANTIBIOTICS. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT THE SURGERY WAS AN UNEVENTFUL COMBINED PHACO AND GFD IMPLANTATION IN THE RIGHT EYE WITH ADDITIONAL METHYLAZIRINOPYRROLOINDOLEDIONE ANTINEOPLASTIC ANTIBIOTIC NEEDLINGS ON (B)(6) 2012 AND (B)(6) 2012. ULTIMATELY FAILED AND HAVE SEEN ANTERIOR MIGRATION OF GDF FOOTPLATE FOR SEVERAL YEARS THROUGH SCLERAL FLAP AND NOW ERODED THRU CONJUNCTIVA FIRST NOTED ON (B)(6) 2019 ON ROUTINE GLAUCOMA FOLLOW UP AND NOT SYMPTOMATIC FROM EROSION. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT HE BELIEVES THAT THE DEVICE FAILURE IS SECONDARY TO "NATURAL HEALING" TENDENCIES/SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256301 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. ALCUNK00059 112409

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention