BEUDAMED
    FDA Recall 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 · Initiated December 18, 2017

    Recall

    Recall Number
    Z-1744-2020
    Event Number
    85261
    Firm
    Johnson & Johnson Vision Care, Inc.
    FEI Number
    1000222023
    Product Code
    MVN
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    December 18, 2017
    Terminated
    June 10, 2020
    Address
    7500 Centurion Pkwy, Jacksonville, FL, 32256-0517

    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.

    Action

    Johnson & Johnson Vision Care Inc., notified customers on 12/18/2017 via Recall Notification letter. Included with the Recall Notification Letter was a Customer Reply Form which the customer is instructed to fax back to the firm.

    Distribution

    Nationwide US.

    Quantity

    150 lenses.