medical Class II Updated 2022-06-29

Alcon Laboratories Ireland, Ltd recalls Alcon Clareon IOL with AutonoMe Delivery System

Recalled Product

Alcon Clareon IOL with AutonoMe Delivery System


Hazard / Issue

Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.

Issued by

FDA

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