BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 6083262 · Received November 7, 2016

    Report

    Report Number
    3003701944-2016-00210
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 7, 2016
    Report Date
    December 22, 2016
    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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DATA REGARDING PRODUCT IDENTITY WAS RECEIVED I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ROOT CAUSE IS EXTERNAL - OTHER: THIS IS A KNOWN TRANSIENT COMPLICATION OF THE SURGICAL PROCEDURE, NOT DEVICE RELATED. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR OF OPHTHALMOLOGY REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANTATION PROCEDURE, EXCESSIVE FILTRATION OCCURRED CAUSING HYPOTONY AND A SHALLOW ANTERIOR CHAMBER. ON POSTOPERATIVE DAY ONE LOW INTRAOCULAR PRESSURE WAS OBSERVED. ON POSTOPERATIVE DAY TWO, ADHESIONS OF THE PERIPHERAL PORTION OF THE ANTERIOR CHAMBER WAS OBSERVED. A PRESSURE PATCH WAS APPLIED TO AVOID EXCESSIVE FILTRATION. ONE WEEK FOLLOWING THE INITIAL PROCEDURE SUTURES WERE ADDED. ADDITIONAL FOLLOW UP RECEIVED SHOWED THAT THE PATIENT HAD EXPERIENCED A CHOROIDAL HEMORRHAGE, AND UNDERWENT A VITRECTOMY DURING WHICH THE DEVICE WAS REMOVED. SURGEON RELAYED THAT THESE SUBSEQUENT EVENTS; CHOROIDAL HEMORRHAGE AND THE EVENTS THAT FOLLOWED, WERE CONSIDERED AS NON-CAUSAL WITH REGARDS TO THE RELATIONSHIP BETWEEN THE DEVICE AND THESE EVENTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT AT THE TIME OF THE GFD INSERTION, EXCESSIVE FILTRATION WAS STRONGLY OBSERVED. SINCE THE OPENING WAS EXPOSED, THE SURGERY WAS TERMINATED WITH A SHALLOW ANTERIOR CHAMBER. AFTER THE SURGERY, THE HYPOTONY WORSENED BECAUSE OF THE SHALLOW ANTERIOR CHAMBER AND THE GFD WAS CONFIRMED TO BE TOUCHING THE IRIS ON THE FIRST POSTOPERATIVE DAY. APPROXIMATELY, TWO WEEKS LATER, THE GFD WAS REMOVED AND THE PATIENT WAS HOSPITALIZED FOR ELEVEN DAYS. THE PATIENT¿S CONDITION IS PERSISTENT. ACCORDING TO THE SURGEON, THE CAUSALITY IS DEFINITELY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732640 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| O| R