BEUDAMED
    FDA Recall Terminated

    American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.

    Recall: Z-1808-2009 · Initiated March 24, 2009

    Recall

    Recall Number
    Z-1808-2009
    Event Number
    52697
    Firm
    American Optisurgical Inc
    FEI Number
    1000135560
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    March 24, 2009
    Posted
    September 4, 2009
    Terminated
    September 4, 2009
    Address
    25501 Arctic Ocean Dr, Lake Forest, CA, 92630

    Description

    American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.

    Reason

    Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk.

    Action

    American Optisurgery sent an E-mail to customers on April 2, 2009 stating the reason for recall and informed them to immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify customers and identify them at once of this product recall. Their notification to customers may be enhanced by including a copy of this recall notification letter. They were then told to refer to the enclosed Recall Questionnaire for instructions on what to do with the recalled product: The recall should be carried out to the user level and return the enclosed response form as soon as possible. If there are any questions, they are advised to contact David Salzberg at (800) 576-1266.

    Distribution

    Worldwide distribution: USA (California), Brazil, Algeria, France, South Korea, India, and Peru.

    Quantity

    12 units