Alcon Clareon IOL with AutonoMe Delivery System — Class II medical device recall Z-1269-2022
Terminated recall by Alcon Laboratories Ireland, Ltd, reported 2022-06-29, distributed in AL, CA, FL, GA, IA, IL, KY, LA…. Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overl
| Recall number | Z-1269-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Laboratories Ireland, Ltd, Cork, Ireland |
| Recall initiated | 2022-05-11 |
| Classified | 2022-06-17 |
| Reported by FDA | 2022-06-29 |
| Terminated | 2025-02-05 |
| Distributed | AL, CA, FL, GA, IA, IL, KY, LA, MI, MO, NY, OH, OK, TX, VA, WI |
| Countries outside the US | CH, CZ, DE, ES, FR, IN, SK |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00380652393669, 00380652393799 |
| Lot numbers | 25238769, 25238775 |
| Model numbers | CNA0T0.175, CNA0T0.240 |
Product
Alcon Clareon IOL with AutonoMe Delivery System
Reason for recall
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
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-1269-2022. 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.