BEUDAMED
    FDA Recall Terminated

    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

    Recall: Z-1210-2018 · Initiated October 19, 2017

    Recall

    Recall Number
    Z-1210-2018
    Event Number
    79152
    Firm
    Johnson & Johnson Vision Care, Inc.
    FEI Number
    1000222023
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 19, 2017
    Terminated
    June 12, 2020
    Address
    7500 Centurion Pkwy, Jacksonville, FL, 32256-0517

    Description

    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

    Reason

    Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

    Action

    On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil

    Quantity

    165,750