Device Recall STAR S4 with Variable Spot Scanning Excimer System (STAR S4)

  • Modèle / numéro de série
    Model 0030-4077 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • 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. .
  • Description du dispositif
    STAR S4 with Variable Spot Scanning Excimer System (STAR S4) || 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.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Medical Optics, Inc., 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Société-mère du fabricant (2017)
  • Source
    USFDA