Alcon Clareon IOL with AutonoMe Delivery System recall: Labeling Error
Alcon Clareon IOL with AutonoMe Delivery System
Why was Alcon Clareon IOL with AutonoMe Delivery System recalled?
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Alcon Clareon IOL with AutonoMe Delivery System
- Recalling firm
- Alcon Laboratories Ireland, Ltd
- Quantity
- 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
- 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
- Recall date
- June 29, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)