BEUDAMED
    FDA Enforcement Class II Terminated

    Alcon Clareon IOL with AutonoMe Delivery System

    Recall: Z-1269-2022 · Reported June 29, 2022

    Enforcement

    Recall Number
    Z-1269-2022
    Event ID
    90194
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Laboratories Ireland, Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 29, 2022
    Initiation Date
    May 11, 2022
    Classification Date
    June 17, 2022
    Termination Date
    February 5, 2025
    Address
    Cork Business And Technology Park, Model Farm Road, Cork, N/A, Ireland

    Description

    Alcon Clareon IOL with AutonoMe Delivery System

    Reason

    Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.

    Code Info

    Catalog/Model Number: CNA0T0.175 UDI Code: (01) 00380652393669 (17) 240720 (21) 25238769000 (11) 210722 (240) CNA0T0175 Lot number: 25238769 Catalog/Model Number: CNA0T0.240 UDI Code: (01) 00380652393799 (17) 240720 (21) 25238775000 (11) 210722 (240) CNA0T0240 Lot Number: 25238775

    Distribution

    U.S.: AL, CA, FL, GA, IA, IL, KY, LA, MI, MO, NY, OH,OK, TX, VA, and WI O.U.S.: Czech Republic, France, Germany, India, Slovakia, Spain, and Switzerland

    Quantity

    139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)