OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US...
FDA Device Recall #Z-1515-2015 — Class II — February 20, 2015
Recall Summary
| Recall Number | Z-1515-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 20, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Medical Optics, Inc. |
| Location | Milpitas, CA |
| Product Type | Devices |
| Quantity | 202 |
Product Description
OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Reason for Recall
Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of, Canada, Germany, Switzerland, Australia, Spain, Japan, Great Britain, France, Netherlands, Austria, Singapore, South Korea, India, Thailand, Colombia, Ecuador, Italy, Brazil, Egypt, Tunsia, Belgium, Mexico, Greece, Guatemala, Chile, Turkey, Peru, Hong Kong, Saudi Arabia, Bangladesh, and Dominican Rep.
Lot / Code Information
Device Serial No. (U.S.) 44055311 44055611 44055811 44056012 44056312 44056612 44056712 44056812 44057312 44057812 44058012 44058212 44058312 44059212 44059312 44059612 44059712 44059812 44059912 44060012 44060112 44060312 44060412 44060612 44060712 44060912 44061012 44061412 44061612 44061812 44062013 44062213 44062413 44062613 44062813 44063113 44063313 44063413 44063513 44063613 44063713 44063813 44063913 44064113 44064313 44064413 44064513 44064613 44064713 44064813 44065013 44065113 44065213 44065313 44065413 44065613 44066213 44066413 44066613 44066914 44067014 44068014 44068314 44068914 44069114 44069414 44069814 44070414 44070914 44071914 44072114 44072414 44072714 44072814 44072914 44073014 44073114 44073214 44073314 44073514 44073714 44074114 44074514 44074614 44074814 44100714 44100814 44101014 44101114 44101414 44101614 44102514 44102614 44102714 Device Serial No. (Outside U.S.) 44055211 44055411 44055711 44055911 44056112 44056212 44056412 44056512 44056912 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 44062913 44063013 44063213 44064013 44064213 44065513 44065713 44065813 44065913 44066313 44066513 44066713 44066813 44067114 44067214 44067414 44067514 44067614 44067714 44067914 44068114 44068214 44068414 44068514 44068614 44069014 44069214 44069314 44069514 44069914 44070014 44070114 44070214 44070314 44070514 44070614 44070714 44070814 44071014 44071114 44071214 44071314 44071414 44071514 44071614 44071714 44071814 44072014 44072214 44072314 44072514 44072614 44073414 44073614 44073814 44073914 44074014 44074214 44074314 44074414 44074714 44074914 44100114 44100214 44100614 44100914 44101314 44101514 44101714 44101814 44101914 44102014 44102114 44064913R
Other Recalls from Abbott Medical Optics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0048-2014 | Class II | STAR Excimer Laser System with Variable Spot Sc... | Sep 16, 2013 |
| Z-0047-2014 | Class II | STAR ActiveTrak Excimer Laser System, Model: ST... | Sep 16, 2013 |
| Z-0046-2014 | Class II | STAR Excimer Laser System, Model: STAR S2, Cata... | Sep 16, 2013 |
| Z-0049-2014 | Class II | STAR Excimer Laser System, Model STAR S4 IR, Ca... | Sep 16, 2013 |
| Z-1540-2013 | Class II | STAR S4 with Variable Spot Scanning Excimer Sy... | May 28, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.