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U.S. Department of Health and Human Services

Class 2 Device Recall STAR S4 IR Excimer Laser System; Software Version 5.16

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 Class 2 Device Recall STAR S4 IR Excimer Laser System; Software Version 5.16see related information
Date Initiated by FirmJuly 18, 2011
Date PostedAugust 09, 2011
Recall Status1 Terminated 3 on September 10, 2013
Recall NumberZ-2970-2011
Recall Event ID 59330
PMA NumberP930016S019 
Product Classification Excimer laser system - Product Code LZS
ProductSTAR S4 IR Excimer Laser System; Software Version 5.16 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 # 0030-4793
Recalling Firm/
Manufacturer		 AMO Manufacturing USA, LLC
510 Cottonwood Dr
Milpitas CA 95035-7403
For Additional Information ContactSandra 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
ActionAbbott 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 Commerce673 total - v5.00 -5.22
DistributionWorldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LZS
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