BEUDAMED
    FDA Recall Open, Classified

    Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

    Recall: Z-0086-2023 · Initiated September 1, 2022

    Recall

    Recall Number
    Z-0086-2023
    Event Number
    90847
    Firm
    Johnson & Johnson Surgical Vision, Inc.
    FEI Number
    3012236936
    Product Code
    HQC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 1, 2022
    Posted
    October 12, 2022
    Address
    31 Technology Dr, Ste 200, Irvine, CA, 92618-2302

    Description

    Veritas Advanced Infusion Packs. Used in ophthalmic procedures.

    Reason

    As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

    Action

    On 09/01-02/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS 2-Day Mail to customers informing them that the firm is recalling specific lots of VERITAS Advanced Infusion Packs due to the potential for the irrigation luer to crack or break which could lead to reduced irrigation pressure during surgery, associated with an unstable anterior chamber. Customers are required to: 1.Identify if any of their inventory contains VERITAS Packs with a lot number listed on page 5. 2.Immediately discontinue using and remove from their inventory all affected VERITAS Packs. No other VERITAS Advanced Infusion Packs are affected by this recall. 3.Complete the attached Customer Reply Form (on page 4). We require this information for reconciliation purposes with regulatory agencies, even if you have no inventory. If customers have product to be returned: -Complete the Customer Reply Form, noting the lot numbers of the VERITAS Packs. -Contact Customer Support at 1-877-266-4543 Option 2 to obtain a RGA number and arrange the product return. -Email Customer Reply Form to [email protected] within 3 business days of receipt of this letter. - A credit will be issued upon receipt of the customer reply form and product. If you do not have product to be returned: Email Customer Reply Form to [email protected] For questions or concerns, contact 1-877-266-4543 Option 2.

    Distribution

    Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL IN, KY LA, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, VA, and WA; Australia, Azerbaijan, Belgium, Brazil, Canada, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan, Jordan, Kuwait, Morocco, Netherlands, New Zealand, Oman, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom

    Quantity

    53,624 units