BEUDAMED
    FDA Enforcement Class II Terminated

    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

    Recall: Z-1210-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1210-2018
    Event ID
    79152
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Johnson & Johnson Vision Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    October 19, 2017
    Classification Date
    March 27, 2018
    Termination Date
    June 12, 2020
    Address
    7500 Centurion Pkwy, Jacksonville, FL, 32256-0517, United States

    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.

    Code Info

    Lot B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J Vision Care Inc. Jacksonville, FL Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J Vision Care Ireland Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D

    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