BEUDAMED
    FDA Recall Open, Classified

    ACUVUE OASYS MAX 1-Day MULTIFOCAL

    Recall: Z-2163-2025 · Initiated June 12, 2025

    Recall

    Recall Number
    Z-2163-2025
    Event Number
    97095
    Firm
    Johnson & Johnson Vision Care, Inc.
    FEI Number
    1000222023
    Product Code
    LPL
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 12, 2025
    Posted
    July 23, 2025
    Address
    7500 Centurion Pkwy, Jacksonville, FL, 32256-0517

    Description

    ACUVUE OASYS MAX 1-Day MULTIFOCAL

    Reason

    Due to defects (bubbles/voids) identified during standard finished goods testing

    Action

    On 06/12/2025, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL" letter to customers to inform them that the firm identified high density of microbubbles (microscopic voids within the contact lens) observed in specific limited lots during our quality control checks. Customers are instructed to: 1. Review if any of their inventory contains contact lenses impacted lot numbers. 2. STOP using and remove from their inventory all affected product. Note: They can continue to use all other lots not affected by this voluntary recall. 3. Pass this notice on to anyone in their organization who needs to be aware of the issue and ensure that they maintain awareness as necessary. 4. Please contact their patients that may have received any of the affected product and ask them return for replacement. 5. Global Post Market Safety, at 1-800-843-2020, will arrange for the return and replacement of any affected product. 6. Complete the enclosed Customer Reply Form and return via email to [email protected] or via fax to 904-229-0300, EVEN IF CUSTOMERS 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 emailed or faxed within 3 business days of receipt of this letter. For questions or assistance - contact Johnson & Johnson Vision Care Global Post Market Safety, at 1-800-843-2020

    Distribution

    Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC TN, TX, UT, VA, WA, WI, and WY. The countries of Belgium, Bermuda, Canada, Switzerland, Denmark, Germany, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden, Singapore, and South Korea.

    Quantity

    114,165 lenses