BEUDAMED
    FDA Recall Terminated

    STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.

    Recall: Z-1539-2013 · Initiated May 28, 2013

    Recall

    Recall Number
    Z-1539-2013
    Event Number
    65285
    Firm
    Abbott Medical Optics, Inc.
    FEI Number
    3006695864
    Product Code
    LZS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 28, 2013
    Posted
    June 13, 2013
    Terminated
    November 12, 2014
    Address
    510 Cottonwood Dr, Milpitas, CA, 95035-7403

    Description

    STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.

    Reason

    Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.

    Action

    AMO Manufacturing sent an Advisory Notice dated May 28, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the attached advisory notice to all affected customers in their assigned region. Customers were instructed to notify each surgeion at their site and complete and return the attached form to AMO via fax as an an acknowledgement of receipt of this advisory notice and that they understand the information contained within the letter. Customers with questions were instructed to contact their regional contact. For questions regarding this recall call 408-273-4016.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. .

    Quantity

    1,882 total all systems