BEUDAMED
    FDA Recall Terminated

    ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50

    Recall: Z-1865-2021 · Initiated May 6, 2021

    Recall

    Recall Number
    Z-1865-2021
    Event Number
    87947
    Firm
    Johnson & Johnson Vision Care, Inc.
    FEI Number
    1000222023
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 6, 2021
    Terminated
    November 2, 2021
    Address
    7500 Centurion Pkwy, Jacksonville, FL, 32256-0517

    Description

    ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50

    Reason

    Potential that a limited number of individual contact lens packages have an incomplete packaging seal.

    Action

    On May 4th the firm sent a letter to its consignees with the following instructions: Since you have received potentially affected product, please immediately take the following actions: 1. Review your inventory and determine if you have ACUVUE Vita Brand Diagnostic lenses from the impacted lot: B00WWWL 2. STOP using and remove from your inventory all affected product. Note: You can continue to use all other lots not affected by this voluntary recall. 3. Please pass this notice on to anyone in your organization who needs to be aware of the issue and ensure that they maintain awareness as necessary. 4. Please contact your patients that may have received any of the affected product and ask them to discontinue use and return to you for replacement. 5. Customer Service, at 1-800-843-2020, will arrange for you the return and replacement of any affected product. 6. Complete the enclosed Customer Reply Form and return via fax to 904-443-3442 or via email to [email protected], EVEN IF YOU HAVE NO INVENTORY REMAINING affected by this recall. JJVC requires this information for reconciliation purposes with regulatory agencies. The completed Customer Reply Form should be faxed or emailed within 3 business days of receipt of this letter.

    Distribution

    Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.

    Quantity

    6,780 lenses