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U.S. Department of Health and Human Services

Class 2 Device Recall Catalys Precision Laser System

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  Class 2 Device Recall Catalys Precision Laser System see related information
Date Initiated by Firm February 20, 2015
Date Posted May 28, 2015
Recall Status1 Terminated 3 on December 08, 2015
Recall Number Z-1683-2015
Recall Event ID 70672
510(K)Number K141079  
Product Classification Ophthalmic femtosecond laser - Product Code OOE
Product Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05

The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Code Information Software version 3.00.05: Serial numbers - US:  44066413 44063113 44065413 44066213 44102714 44060012 44064813 44061012 44061812 44101614 44068314 44056612 44063713 44102614 44068914 44073514 44074814 44061612 44073714 44056312 44061412 44066613 44069414 44069814 44070914 44072714 44073014 44073114 44074514 44074614 44100714 44068014 44060612 44062813 44066914 44056012 44062213 44064513 44101014 44100814 44060312 44060412 44063513 44056712 44063313 44063913 44073314 44065613 44058312 44065013 44072114 44072414 44071914 44062613 44065213 44059912 44057312 44059712 44058212 44072814 44060712 44060112 44057812 44058012 44059612 44069114  Serial numbers - OUS:  44055211 44055411 44055711 44056112 44056212 44056412 44056512 44056912 44057112 44057212 44057412 44057512 44057712 44057912 44058512 44058612 44058912 44059012 44059112 44059412 44059512 44061212 44061312 44061512 44061712 44061913 44062113 44062313 44063213 44064013 44064213 44065513 44066313 44066813 44067214 44067414 44067514 44067714 44068114 44068414 44068614 44069214 44069514 44069914 44070014 44070114 44070614 44070714 44071014 44071214 44071314 44071414 44071514 44071714 44071814 44072214 44072314 44072614 44073414 44074014 44074214 44074414 44074714 44074914 44100114 44100614 44101714 44101814 44101914 44102014.  
Recalling Firm/
Manufacturer		 Optimedica Corporation
1310 Moffett Park Dr
Sunnyvale CA 94089-1133
For Additional Information Contact Christopher Carnahan
408-273-4016
Manufacturer Reason
for Recall		 Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.
FDA Determined
Cause 2		 Software design
Action Abbott sent an Advisory Notice dated March 5, 2015, vis Fed Ex overnight to all affected customers. Out of State accounts will be notified through their distributor after letters are translated into local language. Recall notification letters advise customers of issue with CATALYS System using software version 3.00.05. The letter actually covers two issues, the cataract templates being the same for both eyes, and a loss of suction during treatment that may result in scoring the cornea. In both cases the issue is explained and users are advised to use mitigation listed to prevent injury. AMO is developing an update to software that will correct these issues and users will be advised when it is available for installation. All users of the device should be made aware of the issues and each surgeon is requested to sign the acknowledgement form to verify their receipt and understanding. The acknowledgement for should be returned to Abbott Medical Optics per instructions. Questions in the US may be directed to AMO Technical support at 1-855-662-0911.
Quantity in Commerce 171 distributed Worldwide
Distribution Worldwide Distribution - US Nationwide, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Brazil, Italy, Belgium, Egypt, Colombia, Hong Kong, and Canada.
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.
510(K) Database 510(K)s with Product Code = OOE and Original Applicant = OPTIMEDICA CORPORATION
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