BEUDAMED
    FDA Recall Terminated

    LADARVision Excimer Laser System.

    Recall: Z-1147-06 · Initiated August 1, 2005

    Recall

    Recall Number
    Z-1147-06
    Event Number
    32866
    Firm
    Alcon Laboratories, Inc.
    FEI Number
    3000209733
    Product Code
    LZS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2005
    Posted
    June 21, 2006
    Terminated
    July 6, 2012
    Address
    2800 Discovery Dr, Orlando, FL, 32826-3010

    Description

    LADARVision Excimer Laser System.

    Reason

    Alcon has identified a software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on CustomCornea procedures, possibly adversely affecting clinical outcomes.

    Action

    A Medical Device Safety Alert dated August 1, 2005, has been issued to all consignees. Each consignee was issued a Response To Safety Alert form to acknowledge receipt of the Safety Alert. A Field Service Engineer will visit to install the revised software.

    Distribution

    There have been 285 units distributed in the US and 151 units distributed to International Alcon Affiliates.

    Quantity

    436