BEUDAMED
    FDA Recall 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 · Initiated January 12, 2018

    Recall

    Recall Number
    Z-0779-2018
    Event Number
    79226
    Firm
    Alcon Research, LTD. 9965 Buffalo Speedway
    FEI Number
    1000117501
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 12, 2018
    Terminated
    February 4, 2022
    Address
    Houston, TX, 77054-1309

    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.

    Action

    Alcon sent an Urgent Field Safety Notice Recall notification letters to affected foreign medical users/distributors beginning January 12, 2018. For further questions please call (713) 668-9100.

    Distribution

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

    Quantity

    52 units