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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Optimedica Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0649-2014
Related Recalls
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.