Alcon Research LLC: Device Recall
Recall #Z-0835-2025 · 11/13/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0835-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Alcon Research LLC
- Status
- Ongoing
- Date Initiated
- 11/13/2024
- Location
- Fort Worth, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41718 units
Reason for Recall
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.
Product Description
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
Distribution Pattern
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
Other Recalls by Alcon Research LLC
- Class I: Dangerous 11/24/2025
- Class II: Risk 09/30/2025
- Class II: Risk 09/15/2025
- Class II: Risk 08/05/2025
- Class II: Risk 08/05/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.