Alcon Clareon IOL with AutonoMe Delivery System

Class I - Dangerous

🏥 Medical Devices Recalled: May 11, 2022 Alcon Laboratories Ireland Infusion Pumps

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Alcon Laboratories Ireland, Ltd
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Alcon Clareon IOL with AutonoMe Delivery System

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: AL, CA, FL, GA, IA, IL, KY, LA, MI, MO, NY, OH, OK, TX, VA, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1269-2022