Class 2 Device Recall STAR S4 IR Excimer Laser System; Software Version 5.21

• Date Initiated by Firm: July 18, 2011
• Date Posted: August 09, 2011
• Recall Status: Terminated on September 10, 2013
• Recall Number: Z-2973-2011
• Recall Event ID: 59330
• PMA Number: P930016S019
• Product Classification: Excimer laser system - Product Code LZS
• Product: STAR S4 IR Excimer Laser System; Software Version 5.21 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.
• Code Information: Model # 0030-4825
• Recalling Firm/ Manufacturer: AMO Manufacturing USA, LLC; 510 Cottonwood Dr; Milpitas CA 95035-7403
• For Additional Information Contact: Sandra Selvaggi; 714-247-8656
• Manufacturer Reason for Recall: Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version.
• FDA Determined Cause: Software design
• Action: Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number. Contact an AMO representative for questions regarding this notice.
• Quantity in Commerce: 673 total - v5.00 -5.22
• Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.
• 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