Alcon Research LLC Recall 94989
Description: Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 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-2655-2024 |
| Event ID | 94989 |
| Event Description | Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 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 | 14,216 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: 8065911901; UDI-DI: 00380659119019; Lot numbers: 16F1KH, 16F1KJ, 16F1P7, 16FXNJ, 16J9AE. |
| Center Classification Date | 20240816 |
| Recall Initiation Date | 20240715 |
| Recalling Firm | Alcon Research LLC |
| Initial Notification | Letter |
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