BEUDAMED
    FDA Recall Terminated

    FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plains, IL 60018, USA, Made in USA, Sterile.

    Recall: Z-0405-03 · Initiated December 16, 2002

    Recall

    Recall Number
    Z-0405-03
    Event Number
    25221
    Firm
    Ciba Vision Corporation
    FEI Number
    1053053
    Product Code
    LPM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2002
    Posted
    December 31, 2002
    Terminated
    August 7, 2003
    Address
    11460 Johns Creek Parkway, Duluth, GA, 30097

    Description

    FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plains, IL 60018, USA, Made in USA, Sterile.

    Reason

    Mislabeling

    Action

    Each customer was sent a recall letter via traceable mail on 12/16/02 with a Business Reply Form and a pre-paid air bill to return the product and completed form was attached. Customers who have not responded in 30 days will be contacted by telephone.

    Distribution

    01CA, FL, IL, IN, MA, MO, MS, OH, TX, UT, WI; Australia, Canada. There were no government accounts involved. CIBA Vision Canada, Ontario, Canada.

    Quantity

    35 units (multi-pack/six lenses per unit).