Z-1269-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 29, 2022
- Initiation Date
- May 11, 2022
- Termination Date
- February 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
Product Description
Alcon Clareon IOL with AutonoMe Delivery System
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 Pattern
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
Code Information
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