FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

Affected by this recall?

Get a free legal consultation about this recall.

Talk to a Lawyer →

Affiliate link

Products

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 P
Brand
Optimedica Corporation
UPC
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.

Units Affected

78 (39 in US, 39 internationally)

Related Recalls

FDA DEVICE

Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical

 FDA DEVICE

AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.