BEUDAMED
    FDA Enforcement Class II Ongoing

    Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A

    Recall: Z-2646-2024 · Reported August 28, 2024

    Enforcement

    Recall Number
    Z-2646-2024
    Event ID
    94989
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Alcon Research LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2024
    Initiation Date
    July 15, 2024
    Classification Date
    August 16, 2024
    Address
    Aspex Facility, 6201 South Fwy, Fort Worth, TX, 76134-2099, United States

    Description

    Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A

    Reason

    Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

    Code Info

    Model/Catalog Number: 8065751658; UDI-DI: 00380657516582; Lot Numbers: 16C4MR, 16K84T, 16FXTD.

    Distribution

    Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

    Quantity

    3,721 units