Alcon Laboratories Ireland, Ltd Cork Business And Technology Park Model Farm Road Cork Ireland Alcon Clareon IOL with AutonoMe Delivery System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alcon Clareon IOL with AutonoMe Delivery System
Brand
Alcon Laboratories Ireland, Ltd Cork Business And Technology Park Model Farm Road Cork Ireland
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Alcon Laboratories Ireland, Ltd Cork Business And Technology Park Model Farm Road Cork Ireland is recalling Alcon Clareon IOL with AutonoMe Delivery System due to Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attribute. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Recommended Action
Per FDA guidance
On 05/11/2022, Alcon Laboratories sent an "URGENT: VOLUNTARY MEDICAL DEVICE REMOVAL" Letter via FedEx overnight informing customer that the firm has initiated a removal of one specific lot (25238769) of the Clareon IOL with AutonoMe Delivery System (CNA0T0.175). Based on the firm's investigation, there is the potential for limited number of 24.0D lenses to be included within this lot of the 17.5D Clareon IOL AutonoMe Delivery System. Customers are asked to locate and return the Alcon 17.5D Clareon IOL AutonoMe Delivery System with lot 25238769. An Alcon associate will reach out to customers directly to arrange for the return and replacement of the affected products. For questions, contact Alcon Customer Service at 1-800-862-5266 or contact their Alcon Sales Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, FL, GA, IL, IA, KY, LA, MI, MO, NY, OH, OK, TX, VA, WI
Page updated: Jan 10, 2026