BEUDAMED
    FDA Enforcement Class II Terminated

    ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.

    Recall: Z-1131-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1131-2019
    Event ID
    82402
    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 17, 2019
    Initiation Date
    March 11, 2019
    Classification Date
    April 11, 2019
    Termination Date
    December 6, 2021
    Address
    7500 Centurion Pkwy, N/A, Jacksonville, FL, 32256-0517, United States

    Description

    ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.

    Reason

    One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.

    Code Info

    Lot Number on box and individual contact lens package: B00RWF0. UPC: 733905669460

    Distribution

    Distributed to California.

    Quantity

    300 lenses