BEUDAMED
    FDA Recall Terminated

    ''Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91

    Recall: Z-1078-03 · Initiated July 21, 2003

    Recall

    Recall Number
    Z-1078-03
    Event Number
    26816
    Firm
    Alcon Laboratories, Inc.
    FEI Number
    3000209733
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2003
    Posted
    August 6, 2003
    Terminated
    January 20, 2010
    Address
    2800 Discovery Dr., Orlando, FL, 32826

    Description

    ''Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91

    Reason

    Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly.

    Action

    The firm mailed their 'Urgent Medical Device Safety Alert' letters to health care professtionals on July 21, 2003 along with a response form. The letter alerts the user to the problem and also how to assure that no erroneous data was saved. The letter also states that a Service Representative will be visiting to install a corrective software version 7.93. The version was completed at the start of the recall and service representative visits to install the software upgrade began approximately 7/22/03.

    Distribution

    109 U.S. customers and 48 international device locations. There were 12 devices on-hand.

    Quantity

    157