Medical Device Recall: Z-1539-2013

FDA Recalls dataset · Firm: Abbott Medical Optics, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-05-28 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1539-2013.

Recall Res Number
Z-1539-2013
Recalling Firm / Manufacturer
Abbott Medical Optics, Inc.
FEI Number
3006695864
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-05-28
Date Posted
2013-06-13
Date Terminated
2014-11-12
Product Code
LZS
Event Number
65285
Product Quantity
1,882 total all systems
Product Description STAR S3 ActiveTrack Excimer System (STAR S3) 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.
Reason for Recall Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
Action Details 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.
Distribution Pattern 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. .
Code Information / Serial Numbers Model 0030-4864 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.

Related Establishments / Registrations

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