BEUDAMED
    FDA Recall Terminated

    Constellation Vision System, Model: Constellation LT, Catalogue Number: 8065751549 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

    Recall: Z-1928-2010 · Initiated April 30, 2010

    Recall

    Recall Number
    Z-1928-2010
    Event Number
    55648
    Firm
    Alcon Research LTD dba Alcon Laboratories, Inc.
    FEI Number
    1000125771
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 30, 2010
    Posted
    July 13, 2010
    Terminated
    September 19, 2011
    Address
    15800 Alton Pkwy, Irvine, CA, 92618-3818

    Description

    Constellation Vision System, Model: Constellation LT, Catalogue Number: 8065751549 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

    Reason

    Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.

    Action

    The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system. For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.

    Distribution

    Worldwide distribution.

    Quantity

    824 units total