Recall Z-0835-2025— Alcon Research LLC
Class II · Ongoing
Class II FDA medical device recall by Alcon Research LLC, initiated 2024-11-13. It names one FDA 510(k) clearance: K063155. Product: 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. 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..
- Recalling firm
- Alcon Research LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-13
- Firm location
- Fort Worth, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.