BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLON L.C.

    MDR report key: 776123 · Received November 1, 2006

    Report

    Report Number
    2244564-2006-00001
    Event Type
    Injury
    Date Received
    November 1, 2006
    Date of Event
    August 10, 2006
    Report Date
    October 24, 2006
    Manufacturer
    BTG
    Product Code
    BTG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLOUDING OF THE EYE DURING SURGERY; SUSPECTED CORNEAL OPACIFICATION OR EDEMA. SEVERE INFLAMMATORY RESPONSE THE DAY AFTER THE SURGERY. RESOLVED AFTER TREATMENT WITH ANTIBIOTICS AND STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLON L.C. 1% SODIUM HYALURONATE BTG BTG * 518200401

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R