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U.S. Department of Health and Human Services

Class 2 Device Recall STAR S4 IR Excimer System (STAR S4 IR)

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 Class 2 Recall
STAR S4 IR Excimer System (STAR S4 IR)
see related information
Date Posted June 13, 2013
Recall Status1 Open
Recall Number Z-1541-2013
Recall Event ID 65285
Premarket Approval
PMA Number
P930016/S019
Product Classification Excimer Laser System - Product Code LZS
Product STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Code Information Model 0030-2450 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.
Recalling Firm/
Manufacturer
Abbott Medical Optics, Inc.
510 Cottonwood Dr
Milpitas, California 95035-7403
For Additional Information Contact Chris Carnahan
408-273-4016
Manufacturer Reason
for Recall
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
FDA Determined
Cause 2
TRAINING: Use Error
Action AMO Manufacturing sent an Advisory Notice dated May 28, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the attached advisory notice to all affected customers in their assigned region. Customers were instructed to notify each surgeion at their site and complete and return the attached form to AMO via fax as an an acknowledgement of receipt of this advisory notice and that they understand the information contained within the letter. Customers with questions were instructed to contact their regional contact. For questions regarding this recall call 408-273-4016.
Quantity in Commerce 1,882, total all systems
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LZS and Applicant = VISX, INCORPORATED
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