BEUDAMED
    FDA Enforcement Class II Ongoing

    Single-Use Packs, REF: OPO80

    Recall: Z-1007-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1007-2023
    Event ID
    91290
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Johnson & Johnson Surgical Vision, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2023
    Initiation Date
    December 7, 2022
    Classification Date
    January 20, 2023
    Address
    31 Technology Dr Ste 200, N/A, Irvine, CA, 92618-2302, United States

    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.

    Code Info

    UDI-DI/Lot: 05050474573352/60326033

    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