BEUDAMED
    FDA Recall 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 · Initiated March 11, 2019

    Recall

    Recall Number
    Z-1131-2019
    Event Number
    82402
    Firm
    Johnson & Johnson Vision Care, Inc.
    FEI Number
    1000222023
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    March 11, 2019
    Posted
    April 11, 2019
    Terminated
    December 6, 2021
    Address
    7500 Centurion Pkwy, Jacksonville, FL, 32256-0517

    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.

    Action

    Johnson & Johnson Vision Care, Inc. notified the single distributor on about 03/11/2019 via "URGENT ACTION: VOLUNTARY and LIMITED MEDICAL DEVICE RECALL" letter. The letter instructed the consignee to review their inventory to determine if any affected contact lenses are on hand, stop using all affected lenses, provide the recall notification to anyone within the organization that should be aware of the issue, and notify any customers may have received any affected product and request they discontinue use and return any on hand. They advised the consignee to contact Customer Service at 1-800-843-2020 to arrange for the return and replacement of affected lenses, and they were requested to complete and return the Customer Reply Form.

    Distribution

    Distributed to California.

    Quantity

    300 lenses