Z-1269-2022 Class II Terminated
FDA device recall Z-1269-2022 was initiated by Alcon Laboratories Ireland, Ltd on May 11, 2022 and is designated Class II. 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. The recall status is terminated (terminated February 5, 2025). Affected quantity: 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775).
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