Optimedica Corporation: 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.

Recall number

Z-0649-2014

Recalling firm

Optimedica Corporation

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.

Status

Terminated

Initiated

2013-12-20

Posted

2014-01-08

Terminated

2014-06-26

Reason

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.

Root cause

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K121091"]

PMA numbers

not on file

Product code

OOE

Firm FEI

3005675890

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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