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U.S. Department of Health and Human Services

Class 2 Device Recall OptiMedica Catalys

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  Class 2 Device Recall OptiMedica Catalys see related information
Date Initiated by Firm December 20, 2013
Date Posted January 08, 2014
Recall Status1 Terminated 3 on June 26, 2014
Recall Number Z-0649-2014
Recall Event ID 67150
510(K)Number K121091  
Product Classification Ophthalmic femtosecond laser - Product Code OOE
Product Catalys Precision Laser System (United States) - Catalys-U:
Catalys Precision Laser System (International) - Catalys I

200-240V ~, 50/60 Hz, 15A,
(2) 15A Resettable CB:
Tested and complies with FCC Part 15 Class A.

OptiMedica
1310 Moffett Park Drive
Sunnyvale, CA 94089

The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Code Information All units shipped prior to Octotber 18, 2013. US Serial numbers: 44055311, 44055611, 44055811, 44056012, 44056312, 44056612, 44056712,  44056812, 44057312, 44057812, 44058012, 44058212, 44058312, 44059212, 44059312, 44059612, 44059712, 44059812, 44059912, 44060012, 44060112, 44060312, 44060412.  International Serial numbers: 44000811, 44055211, 44055411, 44055711, 44055911, 44056112, 44056212, 44056412, 44056512, 44056912, 44057012, 44057112, 44057212, 44057412, 44057512, 44057612, 44057712, 44057912, 44058112, 44058512, 44058612, 44058912, 44059012. 44059112 44059412 44059512 44060212 44060512 44061112 44061212 44061312 44061512 44061712 44061913 44062113 44062313 44062513 44062913 44063013 44060612 44060712 44060912 44061012 44061412 44061612 44061812 44062013 44062213 44062613 44062813 44063313 44063513 44063613 44063713 44063913. 
Recalling Firm/
Manufacturer		 Optimedica Corporation
1310 Moffett Park Dr
Sunnyvale CA 94089-1133
For Additional Information Contact Paul W. Gardanier
408-850-8604
Manufacturer Reason
for Recall		 Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, OptiMedica, issued an "ADVISORY NOTICE" dated December 20, 2013 to all customers with a Catalys Precision Laser System via Federal Express. OptiMedica also released a Field Service Bulletin (Document No: SB-00065) internally for the impacted product with instructions to implement the corrections through the OptiMedica service organization. The notice describes the product, problem and actions to be taken. The customers were instructed to complete the site header information on the attached fax-back form and return via fax to 1-408-890-4681 within the next three (3) business days or mail to OptiMedica at 1310 Moffette Park Drive, Sunnyvale, CA 94089. If you have any questions related to the operation of the Catalys Precision Laser System or the documentation requirements associated with this letter, please call OptiMedica Technical Support at 1-855-662-0911 and you will be directed to an OptiMedica representative who will be pleased to assist you.
Quantity in Commerce 78 (39 in US, 39 internationally)
Distribution Worldwide Distribution: US (nationwide) including states of: TX, NC, OH, IA, UT, KY, ME, CA, NY, MA. NJ, IL, PA,, TN, FL, MO, GA, HI, SC, NE, MI, and GA and countries of: Dominican Republic, Germany, Switzerland, Australia, Spain, Japan, United Kingdom, Canada, France, The Netherlands, Austria, and Singapore.
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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