| Class 2 Device Recall STAR IR Excimer Laser | |
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/ Manufacturer |
Abbott Medical Optics, Inc. 510 Cottonwood Dr Milpitas CA 95035-7403
|
For Additional Information Contact | Christopher Carnahan 408-273-4100 |
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
|
|
|
|