FDA Device recall Z-0835-2025
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D deli…
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D deli… by Alcon Research, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0835-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-13 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Alcon Research |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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 |
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.
Identifiers
| code_info | GTIN/UDI 10380659777636/ Lot # 15895927 15895928 15895929 15895930 15895931 15895932 15895933 15895934 15895935 158959…GTIN/UDI 10380659777636/ Lot # 15895927 15895928 15895929 15895930 15895931 15895932 15895933 15895934 15895935 15895936 15895937 15895938 15895939 15895940 15895941 15895942 15895965 15895969 15895973 15895977 15899643 15899644 15899687 15899688 15899689 15899690 15899691 15899692 15899693 15899695 15899696 15899697 15899698 15899700 15899701 15899730 15899731 15899732 15899733 15899734 15899735 15899736 15899737 15899738 15899753 15904026 15904027 15904028 15904029 15904030 15904031 15904032 15904033 15904034 15904035 15904036 15904037 15904038 15904039 15904040 15904041 15904042 15904043 15904045 15906851 15906852 15906853 15913832 15913833 15913834 15913835 15913836 15913837 15913838 15913839 15913840 15913841 15913842 15913846 15913850 15913855 15913859 15913862 15913919 15913920 15913921 15913922 15913923 15913924 15913925 15913926 15913927 15913928 15913929 15913930 15913931 15913932 15913933 15913934 15913935 15913936 15913937 15913938 15913939 15913940 15913941 15913942 15913 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0835-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.