Device product
Alcon Clareon IOL with AutonoMe Delivery System
Z-1269-2022
Product summary
- Event
- Event 90194
- Status
- Terminated
- Classification
- Class II
- Quantity
- 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
- Official record key
device-enforcement:Z-1269-2022
Official wording
Reason: Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
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
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
Derived failure modes
-
Labeling or packaging
mislabeling