FDA-Device2022-06-29Class II
Alcon Clareon IOL with AutonoMe Delivery System
Alcon Laboratories Ireland, Ltd
Hazard
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Sold states
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
Affected count
139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
Manufactured in
Cork Business And Technology Park, Model Farm Road, Cork, Ireland
Products
Alcon Clareon IOL with AutonoMe Delivery System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2022Don't want to check this manually?
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