BEUDAMED
    FDA Enforcement Class II Terminated

    ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.

    Recall: Z-1744-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1744-2020
    Event ID
    85261
    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 29, 2020
    Initiation Date
    December 18, 2017
    Classification Date
    April 17, 2020
    Termination Date
    June 10, 2020
    Address
    7500 Centurion Pkwy, N/A, Jacksonville, FL, 32256-0517, United States

    Description

    ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.

    Reason

    Package integrity failure observed during routine shift package integrity testing at an external re-packager.

    Code Info

    Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.

    Distribution

    Nationwide US.

    Quantity

    150 lenses.