BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

    Recall: Z-0779-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0779-2018
    Event ID
    79226
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    January 12, 2018
    Classification Date
    February 28, 2018
    Termination Date
    February 4, 2022
    Address
    9965 Buffalo Speedway, N/A, Houston, TX, 77054-1309, United States

    Description

    Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

    Reason

    Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.

    Code Info

    Lot 507492, 507664, 507539

    Distribution

    Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine

    Quantity

    52 units