BEUDAMED
    FDA Recall Terminated

    Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Lot 1170119, Expiration 2007/10, BC 8.9, DIA 13.8, SPH -1.50, CIBA Vision, Corp, Duluth, GA 30097, Made in USA.

    Recall: Z-0342-03 · Initiated November 12, 2002

    Recall

    Recall Number
    Z-0342-03
    Event Number
    25101
    Firm
    Ciba Vision Corporation
    FEI Number
    1053053
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 12, 2002
    Posted
    December 18, 2002
    Terminated
    April 28, 2003
    Address
    11460 Johns Creek Parkway, Duluth, GA, 30097

    Description

    Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Lot 1170119, Expiration 2007/10, BC 8.9, DIA 13.8, SPH -1.50, CIBA Vision, Corp, Duluth, GA 30097, Made in USA.

    Reason

    Lenses were labeled with the wrong prescription.

    Action

    In the United States, CIBA Vision contacted accounts via traceable letter on 11/12/2002 with attached Business Reply Card form.

    Distribution

    U.S. accounts: CA, GA, IL, MN, NJ, TX, VA. Foreign Distributors: Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Italy, Luxembourg, Moracco, Netherlands, Norway, Portugal, Spain, South Africa, Sweden, Switzerland and the United Arab Emirates. No government accounts involved.

    Quantity

    559 vials (one lens per vial)