BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3682738 · Received March 5, 2014

    Report

    Report Number
    3003701944-2014-00021
    Event Type
    Injury
    Date Received
    March 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 3, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: C MARIOTTI, E DAHAN, M NICOLAI, L LEVITZ AND S BOUEE. LONG-TERM OUTCOMES AND RISK FACTORS FOR FAILURE WITH THE EX-PRESS GLAUCOMA DRAINAGE DEVICE. EYE (2014) 28, 1-8. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT THE INVESTIGATORS REPORTED THAT HYPOTONY (IOP < 6 MMHG) WAS OBSERVED IN 13 EYES (5.2 %) DURING THE FIRST WEEK AFTER SURGERY BUT REQUIRED A POSTOPERATIVE INTERVENTION ONLY IN THREE CASES. THIS REPORT IS FOR THE THREE PATIENTS THAT REQUIRED A POSTOPERATIVE INTERVENTION. THIS IS THE SECOND OF THREE REPORTS BEING FILED FOR THIS LITERATURE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132898 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other