Class 2 Device Recall AMO VISX STAR Excimer Laser System

• Date Initiated by Firm: December 13, 2007
• Date Posted: June 05, 2008
• Recall Status: Terminated on May 05, 2010
• Recall Number: Z-1139-2008
• Recall Event ID: 46393
• PMA Number: P930016
• Product Classification: Laser System - Product Code LZS
• Product: AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051
• Code Information: VISX STAR Excimer Laser Sysem 0030-4864 Chair component of the System 0030-2381 Each chair also has a serial number, which is the same as the serial number assigned to the system it is part of. Serial Numbers: 2129 2146 2181 2197 3028 3030 3031 3036 3480 3624 5346 5635 3751 3863 5345 5088 3113 5065 3938 2158 2177 2204 2205 3254 3387 3397 3754 3937 5030 5122 3023 3194 3435 3456 3732 3830 5027 5283 5313 5334 5382 5456 5566 5606 5643 3037 3122 3130 3233 3246 3874 5006 5021 5032 5125 5224 5415 5671 3574 5306 5695 3816 2200 3029 3284 3293 3528 3536 3697 3712 3731 3802 3840 3927 5012 5014 5034 5064 5079 5151 5153 5154 5175 5231 5267 5287 5307 5317 5410 5559 5573 5656 5720 5779 3884 5649 3314 3974 5495 3241 and 5127
• Recalling Firm/ Manufacturer: VISX INCORPORATED, A SUBSIDIARY OF AMO INC; 3400 Central Expressway; Santa Clara CA 95051
• For Additional Information Contact: Sheree Aronson; 714-247-8290
• Manufacturer Reason for Recall: Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser.
• FDA Determined Cause: Component design/selection
• Action: On December 13, 2007, firm issued an Urgent Safety Notice to all VISX and IntraLase laser owners related to recall. The Safety Notice contains information related to the measures that can be taken to prevent unintentional movement of any chair during other procedures. AMO is initiating a field corrective action, whereby Field Service Engineers will visit each practice that owns both systems to disable the VISX chair back switch. For additional information, please contact AMO at (714) 247-8656.
• Quantity in Commerce: 1,853 units
• Distribution: Worldwide Distribution - USA, including the states of: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV and countries of: Argentina Australia Austria Bahrain Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Cyprus Czech Republic Djibouti Dominican Rep. Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kasachstan Kuwait Lebanon Malaysia Martinique Mexico Mongolia Netherlands New Zealand Norway Oman Pakistan Paraguay Philippines Poland Portugal Russian Fed. Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Trinidad,Tobago Turkey Unit.Arab Emir. Venezuela Vietnam
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LZS