Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge… — Class II medical device recall Z-0835-2025
Ongoing recall by Alcon Research LLC, reported 2025-01-22, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which co
| Recall number | Z-0835-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2024-11-13 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | 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 |
| Countries outside the US | EG, RU |
| Quantity | 41,718 units |
| UPC / GTIN / UDI-DI | 10380659777636 |
| Lot numbers | 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 and 296 more |
| Model numbers | 8065977763 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0835-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.