BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESHLOOK COLOR BLENDS

    MDR report key: 1760721 · Received July 15, 2010

    Report

    Report Number
    1422160-2010-00003
    Event Type
    Injury
    Date Received
    July 15, 2010
    Report Date
    June 16, 2010
    Manufacturer
    CIBAVISION CORPORATION DES PLAINES
    Product Code
    LPM
    PMA / PMN Number
    P830037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    AS THERE WAS NO PRODUCT RETURNED OR LOT INFORMATION PROVIDED, NO DETAILED INVESTIGATION CAN BE PERFORMED. THE USER HAS REPORTED NOT RECEIVING THE PACKAGE INSERT OR ANY DETAILED INFORMATION RELATED TO USER INSTRUCTIONS. THE PRODUCT HAS BEEN REPORTED TO HAVE BEEN PURCHASED FROM AN UNAUTHORIZED SOURCE. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED WHICH ALLEGES THAT A USER (MINOR) EXPERIENCED A CORNEAL ULCER AND PAINFUL INFECTION, RIGHT EYE, (INCLUDING BUT NOT LIMITED TO PSEUDOMONAS) RESULTING IN BLINDNESS AS A RESULT OF USING FRESHLOOK COLORBLENDS NON-PRESCRIPTION CONTACT LENSES OBTAINED FROM A BEAUTY SUPPLY STORE (UNAUTHORIZED SOURCE). THE REPORT STATES THAT THE USER WAS TRYING THE PRODUCT FOR THE FIRST TIME AND THUS ONLY PURCHASED ONE (1) PAIR OF LENSES WITH NO PACKAGE INSERT OR OTHER SUCH INFORMATION PROVIDED AT THE POINT OF SALE. NO FURTHER DETAILS HAVE BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESHLOOK COLOR BLENDS LENSES, SOFT CONTACT, EXTENDED WEAR LPM CIBAVISION CORPORATION DES PLAINES

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability