BEUDAMED
    FDA Enforcement Class II Terminated

    ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

    Recall: Z-1209-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1209-2018
    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 OASYS Brand Contact Lenses with HYDRACLEAR PLUS

    Reason

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

    Code Info

    Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J Vision Care Ireland

    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

    125,763