Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alcon Clareon IOL with AutonoMe Delivery System Recalled by Alcon Laboratories Ireland, Ltd Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Laboratories Ireland, Ltd directly.
Affected Products
Alcon Clareon IOL with AutonoMe Delivery System
Quantity: 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
Why Was This Recalled?
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Where Was This Sold?
This product was distributed to 16 states: AL, CA, FL, GA, IL, IA, KY, LA, MI, MO, NY, OH, OK, TX, VA, WI
About Alcon Laboratories Ireland, Ltd
Alcon Laboratories Ireland, Ltd has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report