Recall Z-1269-2022— Alcon Laboratories Ireland, Ltd
Class II · Terminated
Class II FDA medical device recall by Alcon Laboratories Ireland, Ltd, initiated 2022-05-11, terminated 2025-02-05. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Alcon Laboratories Ireland, Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-05-11
- Terminated
- 2025-02-05
- Firm location
- Cork, Ireland
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.