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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall STAR S4 IR Excimer Laser System; Software Version 5.21 see related information
Date Initiated by Firm July 18, 2011
Date Posted August 09, 2011
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = AMO Manufacturing USA, LLC
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