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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- 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:
- 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.
- 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-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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1683-2015
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