BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK COLORS

    MDR report key: 554151 · Received November 10, 2004

    Report

    Report Number
    1422160-2004-00002
    Event Type
    Injury
    Date Received
    November 10, 2004
    Date of Event
    December 1, 2003
    Report Date
    October 11, 2004
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A CONSUMER RECEIVED TREATMENT FOR A CORNEAL ULCER WHICH OCCURRED IN 12/2003 ASSOCIATED WITH WEAR OF FRESHLOOK COLORS LENSES. CONSUMER RECEIVED TREATMENT FROM 12/2003 TO 3/2004 AND AGAIN FROM 5/2004 TO 8/2004 WHEN CONSUMER RETURNED. CONSUMER REPORTED HAVING HAD SURGERY AS A RESULT OF THE ULCER. SEVERAL REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFO, HOWEVER NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESHLOOK COLORS CONTACT LENS HQL CIBA VISION CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention NONE REPORTED.