BEUDAMED
    FDA Recall Terminated

    LADAR6000 Excimer Laser System

    Recall: Z-0854-2007 · Initiated February 21, 2007

    Recall

    Recall Number
    Z-0854-2007
    Event Number
    37605
    Firm
    Alcon Refractive Horizons, Inc.
    FEI Number
    3000209733
    Product Code
    LZS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2007
    Posted
    June 5, 2007
    Terminated
    March 21, 2017
    Address
    2800 Discovery Dr, Orlando, FL, 32826-3010

    Description

    LADAR6000 Excimer Laser System

    Reason

    Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser. (On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated)

    Action

    Consignees were notified of the recall via two letters. On Feb. 21, 2007, consignees were requested to immediately stop performing all custom cornea myopia procedures and to return an acknowledgement card indicating they have received the alert and understand the required actions. On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated. After meeting with CDRH's Office of Compliance on August 27, 2007, the recalling firm committed to total product removal of the device. Notification will begin in Sept 2007 and will be made by personal visits to each consignee.

    Distribution

    Worldwide Distribution-including USA, Czech Republic, Spain, Australia, Italy, Hong Kong, Vietnam, Singapore, South Korea, and Canada

    Quantity

    102