Alcon Clareon IOL with AutonoMe Delivery System
Check against the official notice below — it lists the full affected range.
Alcon Laboratories Ireland, Ltd. is recalling Alcon Clareon intraocular lenses (IOLs) with AutonoMe Delivery System due to mislabeling of the devices. The mislabeling resulted from partial product mixing during overlapping manufacturing runs caused by improper manufacturing line clearance. Two lots are affected: Lot 25238769 (139 lenses, model CNA0T0.175) and Lot 25238775 (164 lenses, model CNA0T0.240). The affected lenses were distributed in the United States across 16 states (Alabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Michigan, Missouri, New York, Ohio, Oklahoma, Texas, Virginia, and Wisconsin) and internationally in the Czech Republic, France, Germany, India, Slovakia, Spain, and Switzerland.
The recall notice does not specify a remedy or instructions for what consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
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 Quantity: 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775) 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.