BEUDAMED
    FDA Recall Terminated

    OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package).

    Recall: Z-0427-2007 · Initiated January 11, 2007

    Recall

    Recall Number
    Z-0427-2007
    Event Number
    37113
    Firm
    Ciba Vision Corporation
    FEI Number
    1053053
    Product Code
    LPM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 11, 2007
    Posted
    February 15, 2007
    Terminated
    March 21, 2008
    Address
    11460 Johns Creek Pkwy, Duluth, GA, 30097-1518

    Description

    OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package).

    Reason

    Reduced Ion Permeability

    Action

    Consignees were notified by traceable mail on 01/12/2007. Consignees were advised to locate any of the affected lots and return them to CIBA Vision in accordance with the attached instructions. Returned lenses will be destroyed.

    Distribution

    Worldwide, Including USA, Canada, Australia, Benelux, UK and Germany

    Quantity

    11.4 million lenses