FDA Device recall Z-1269-2022
Alcon Clareon IOL with AutonoMe Delivery System
- FDA Device
- Class II
- terminated
- Published 2022-06-29
On 2022-06-29 the FDA classified a Class II recall of Alcon Clareon IOL with AutonoMe Delivery System by Alcon Laboratories Ireland, citing due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1269-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-11 |
| Published | 2022-06-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcon Laboratories Ireland |
| Distribution | AL, CA, FL, GA, IA, IL, KY, LA, MI, MO, NY, OH, OK, TX, VA, WI |
Product
Alcon Clareon IOL with AutonoMe Delivery System
Reason
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Identifiers
| code_info | Catalog/Model Number: CNA0T0.175 UDI Code: (01) 00380652393669 (17) 240720 (21) 25238769000 (11) 210722 (240) CNA0T017…Catalog/Model Number: CNA0T0.175 UDI Code: (01) 00380652393669 (17) 240720 (21) 25238769000 (11) 210722 (240) CNA0T0175 Lot number: 25238769 Catalog/Model Number: CNA0T0.240 UDI Code: (01) 00380652393799 (17) 240720 (21) 25238775000 (11) 210722 (240) CNA0T0240 Lot Number: 25238775 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1269-2022%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.