Alcon Clareon IOL with AutonoMe Delivery System
This recall has been terminated (originally issued May 11, 2022).
- Company
- Alcon Laboratories Ireland, Ltd Cork Business And Technology Park Model Farm Road Cork Ireland
- Recall Initiated
- May 11, 2022
- Terminated
- February 5, 2025
- Recall Number
- Z-1269-2022
- Quantity
- 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
- Official Source
- View on FDA website ↗
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.
Distribution
U.S.: AL, CA, FL, GA, IA, IL, KY, LA, MI, MO, NY, OH,OK, TX, VA, and WI O.U.S.: Czech Republic, France, Germany, India, Slovakia, Spain, and Switzerland
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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.