BEUDAMED
    FDA Recall Terminated

    LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries

    Recall: Z-3081-2017 · Initiated May 25, 2017

    Recall

    Recall Number
    Z-3081-2017
    Event Number
    77480
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    HRM
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 25, 2017
    Terminated
    February 4, 2022
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries

    Reason

    Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base.

    Action

    Alcon sent an Urgent Medical Device Correction letter dated May 25, 2017, to all affected customers. Demonstration units in inventory will be scheduled for retrofit of base and/or upgraded caster configuration through onsite service calls. Customers with questions or concerns were instructed to call 1-800-832-7827. For questions regarding this recall call 817-293-0450.

    Distribution

    Worldwide Distribution - US (nationwide and Puerto Rico): Units were also distributed globally to the following countries: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzegovina, Bulgaria, Canada, Chile, Columbia, Costa Rica, Croatia, Curacao, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Ecuador, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Italy, Jamaica, Japan, Jordan, Kazakhstan, South Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, Ukraine, United Kingdom, and Uzbekistan

    Quantity

    1,074 units