BEUDAMED
    FDA Recall Terminated

    Alcon Clareon IOL with AutonoMe Delivery System

    Recall: Z-1269-2022 · Initiated May 11, 2022

    Recall

    Recall Number
    Z-1269-2022
    Event Number
    90194
    Firm
    Alcon Laboratories Ireland, Ltd Cork Business And Technology Park Model Farm Road Cork Ireland
    FEI Number
    3002808262
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 11, 2022
    Terminated
    February 5, 2025

    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.

    Action

    On 05/11/2022, Alcon Laboratories sent an "URGENT: VOLUNTARY MEDICAL DEVICE REMOVAL" Letter via FedEx overnight informing customer that the firm has initiated a removal of one specific lot (25238769) of the Clareon IOL with AutonoMe Delivery System (CNA0T0.175). Based on the firm's investigation, there is the potential for limited number of 24.0D lenses to be included within this lot of the 17.5D Clareon IOL AutonoMe Delivery System. Customers are asked to locate and return the Alcon 17.5D Clareon IOL AutonoMe Delivery System with lot 25238769. An Alcon associate will reach out to customers directly to arrange for the return and replacement of the affected products. For questions, contact Alcon Customer Service at 1-800-862-5266 or contact their Alcon Sales Representative.

    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)