BEUDAMED
    FDA Recall Terminated

    Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.

    Recall: Z-0365-2008 · Initiated May 30, 2007

    Recall

    Recall Number
    Z-0365-2008
    Event Number
    39353
    Firm
    Visx Inc
    FEI Number
    1221842
    Product Code
    LZS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 30, 2007
    Posted
    January 23, 2008
    Terminated
    April 17, 2008
    Address
    3400 Central Expressway, Santa Clara, CA, 95051

    Description

    Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.

    Reason

    Erroneous Treatment Calculations - Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) Installation of software for a certain brand of computer (Dedicated Computing LLC) can cause a software registry setting for an algorithm that identifies image reflection to be erroneously set in the "off

    Action

    AMO sent an Action Required notification on May 30, 2007, to AMO Certified Physicians. The letter included a CD software update (0070-1721) to be installed by users that provided correct registry parameter settings. Upon completion of installation, a confirmation form will print out. Customers are requested to fax back confirmation to AMO (408-773-7055).

    Distribution

    Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,OR,PA, SC, TN, TX, UT, VA, WA, WI, and WV and countries of Canada and Mexico.

    Quantity

    196 systems are affected in the U.S. and 133 outside of the U.S.