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Alcon Laboratories Ireland, Ltd recalls Alcon Clareon IOL with AutonoMe Delivery System
Recalled June 29, 2022 · FDA recall Z-1269-2022 · Alcon Laboratories Ireland
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. · FDA Class II
Units
139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
Sold at
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
Description
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Product
Alcon Clareon IOL with AutonoMe Delivery System
Manufacturer(s)
Alcon Laboratories Ireland, Ltd
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →