BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 6116369 · Received November 21, 2016

    Report

    Report Number
    3003701944-2016-00218
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    May 11, 2015
    Report Date
    November 21, 2016
    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; THE DEVICE REMAINS IMPLANTED;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 THE MANUFACTURER'S RELEASE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED IN THIS LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT TWO YEARS FOLLOWING A GLAUCOMA FILTRATION DEVICE IMPLANT PROCEDURE FOR EXFOLIATION GLAUCOMA, CORNEAL ENDOTHELIAL CELL LOSS WAS CONFIRMED. ON POSTOPERATIVE DAY ONE, A BANDAGE CONTACT LENS WAS USED AND AN ANTICHOLINERGIC TOPICAL MEDICATION WAS INSTILLED. TWO DAYS FOLLOWING THE PROCEDURE A SHALLOW ANTERIOR CHAMBER WAS NOTED AND A VISCOELASTIC MATERIAL WAS INJECTED INTO THE ANTERIOR CHAMBER TWO DAYS LATER. A SEROUS CHOROIDAL DETACHMENT OCCURRED APPROXIMATELY 3 WEEKS FOLLOWING THE PROCEDURE. THE INTRAOCULAR PRESSURE INCREASED ONE MONTH FOLLOWING THE PROCEDURE SO SUTURE LYSIS WAS PERFORMED. ANOTHER SUTURE LYSIS WAS PERFORMED NINETEEN MONTHS FOLLOWING THE PROCEDURE AND A PROSTAGLANDIN TOPICAL MEDICATION AND AN ALPHA AGONIST TOPICAL MEDICATIONS WERE INSTILLED. A GLAUCOMA VALVE IMPLANT INSERTION WAS PERFORMED APPROXIMATELY THIRTY THREE MONTHS FOLLOWING THE INITIAL PROCEDURE DUE TO POOR INTRAOCULAR PRESSURE LOWERING. THE CORNEAL ENDOTHELIAL CELL LOSS IS CONSIDERED NON-SERIOUS BY THE SURGEON. THE CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT ARE PROBABLE AND THE EVENT IS CONTINUING. THERE HAS BEEN NO TREATMENT FOR THIS EVENT. THE INCREASED INTRAOCULAR PRESSURE EVENT IS CONSIDERED NON-SERIOUS AS WELL. THE CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THIS EVENT IS PROBABLE, BUT THERE ARE OTHER FACTORS ALSO, PER THE SURGEON. THE TREATMENT WAS SURGICAL AND THE PATIENT IS RECOVERING FROM THIS EVENT. THE INITIAL DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768829 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 122816

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other| R MITOMYCIN C 0.04%, APPLICATION TIME 3 MIN