BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 4964315 · Received August 4, 2015

    Report

    Report Number
    3003701944-2015-00616
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 5, 2013
    Report Date
    March 15, 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

    (B)(4)

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE RESULTS FROM THE PRODUCT HISTORY RECORD 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT ONE MONTH FOLLOWING A GLAUCOMA FILTRATION DEVICE/CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) INCREASED. SUTURE LYSIS WAS PERFORMED ON FIVE SEPARATE OCCASIONS. A NEEDLING WAS PERFORMED 6 WEEKS FOLLOWING THE INITIAL SURGERY AND IOP LOWERING TOPICAL MEDICATION WAS ADDED. THE SHUNT WAS REMOVED AND FILTRATION BLEB RECONSTRUCTION WAS PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL DETAILS WERE PROVIDED BY THE SURGEON THAT DURING THE SAME PROCEDURE THAT THE DEVICE WAS REMOVED, A TRABECULECTOMY WAS PERFORMED AFTER CONFIRMING THAT THERE WAS NO AQUEOUS HUMOR LEAKAGE. THE SURGEON INDICATED AN INCOMPLETE FUNCTION OF THE DEVICE WAS THE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE. THE PATIENT IS RECOVERED AS OF FIVE MONTHS FOLLOWING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506639 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL 123033

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R LUMIGAN| COSOPT| ALPHAGAN