Recall Z-0835-2025 ยท KYB Lens, Guide, Intraocular
Alcon Research LLC
Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
| Date | Jan 10, 2025 (initiated Nov 13, 2024) |
| Status | Open, Classified |
| Reason | Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery. |
| Root cause | Process design |
| Action | On 11/13/2024, Alcon Laboratories, Inc. issued a "Urgent: Medical Device Field Correction" to affected consignees. Alcon asked consignees to take the following actions: 1. See Table 1 for list of affected of Monarch III D delivery cartridges distributed to your facility. 2. Review your Monarch III D delivery cartridge inventory to determine if you have any remaining units from the identified lots. 3. If you have remaining units from the identified lots, please dispose of all impacted lots of Monarch III D delivery cartridges identified in Table 1. Please contact Alcon Customer Service to |
| Quantity | 41718 units |
| Distribution | US: AK AL AR AZ CA CO CT DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY OUS: Russia, Egypt |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063155 | MONARCH III IOL DELIVERY SYSTEM Alcon Manufacturing, Ltd., Mar 27, 2007 |