BEUDAMED
    FDA Recall Open, Classified

    Single-Use Packs, REF: OPO80

    Recall: Z-1007-2023 · Initiated December 7, 2022

    Recall

    Recall Number
    Z-1007-2023
    Event Number
    91290
    Firm
    Johnson & Johnson Surgical Vision, Inc.
    FEI Number
    3012236936
    Product Code
    HQC
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 7, 2022
    Posted
    January 20, 2023
    Address
    31 Technology Dr, Ste 200, Irvine, CA, 92618-2302

    Description

    Single-Use Packs, REF: OPO80

    Reason

    Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

    Action

    On 12/07/22, recall notices were sent to customers who were asked to do the following: 1) Discontinue using affected product. 2) Return product to the recalling firm. 3) Complete and return the Customer Reply form via email to [email protected] 4) Distributors, distribute the recall notice to your customers. Customers with questions or concerns can call the firm at 1-877-266-4543 Option 2.

    Distribution

    US: FL, MS, NY, TN, TX, IL, MN, OH. OUS: Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, United Kingdom

    Quantity

    384