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U.S. Department of Health and Human Services

Class 2 Device Recall STAR IR Excimer Laser

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  Class 2 Device Recall STAR IR Excimer Laser see related information
Date Initiated by Firm September 16, 2013
Date Posted October 22, 2013
Recall Status1 Terminated 3 on November 12, 2014
Recall Number Z-0049-2014
Recall Event ID 66304
PMA Number P930016S019 
Product Classification Excimer laser system - Product Code LZS
Product STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC
Milpitas, CA

The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Code Information All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
Recalling Firm/
Abbott Medical Optics, Inc.
510 Cottonwood Dr
Milpitas CA 95035-7403
For Additional Information Contact Christopher Carnahan
Manufacturer Reason
for Recall
This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm, Abbott Medical Optics, Inc., (AMO), sent an "ADVISORY NOTICE and a COVER LETTER FOR ADVISORY NOTICE" dated September 16, 2013 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the Star Notification Acknowledgement form via fax to 1-714-247-4530 within 3 business days or mail to Abbott Medical Optics, 510 Cottonwood Drive, MS 347118, Milpitas, CA 95035, and share this advisory notice with your staff. If you have any questions related to operation of STAR Excimer Laser System or documentation requirements associated with this letter, please call AMO Technical Support at 1-800-511-0911 and you will be directed to an AMO Representative.
Quantity in Commerce 834 units in total
Distribution Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
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 and Original Applicant = AMO Manufacturing USA, LLC