BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE PASS BLADES

    MDR report key: 517195 · Received March 18, 2004

    Report

    Report Number
    2020664-2004-00004
    Event Type
    Injury
    Date Received
    March 18, 2004
    Date of Event
    February 4, 2004
    Report Date
    February 18, 2004
    Manufacturer
    SIS SURGICAL INSTRUMENTS SYSTEMS LTD.
    Product Code
    HNO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FIVE PTS UNDERGOING REFRACTIVE SURGERY PRESENTED WITH BILATERAL DLK (DIFFUSE LAMELLAR KERATITIS) ONE TO TWO DAYS POST OP. ALL PTS WERE TREATED WITH A TOPICAL THERAPY AND ONE PT REQUIRED THE ADDITION OF AN ORAL THERAPY. PT OUTCOME IS EXPECTED TO BE GOOD. IT WAS NOT NECESSARY TO LIFT THE FLAP AND IRRIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE PASS BLADES MICROKERATOME BLADES HNO SIS SURGICAL INSTRUMENTS SYSTEMS LTD. 290709 062004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention AMADEUS MICROKERATOME SYSTEM.