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.

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

Code information: Model 0030-4077 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.

Distribution pattern: 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. .