Alcon Research LLC Recall 94989
Description: Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Alcon Research LLC Recall 94989 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2659-2024 |
| Event ID | 94989 |
| Event Description | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A |
| Product Type | Devices |
| Distribution | Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA |
| Quantity | 2,520 units |
| Recall Reason | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. |
| Device Classification | 20240828 |
| Device Code Info | Model/Catalog Number: 8065983065; UDI-DI: 00380659830655; Lot number: 164RY1. |
| Center Classification Date | 20240816 |
| Recall Initiation Date | 20240715 |
| Recalling Firm | Alcon Research LLC |
| Initial Notification | Letter |
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