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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Clareon IOL with AutonoMe Delivery System

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  Class 2 Device Recall Alcon Clareon IOL with AutonoMe Delivery System see related information
Date Initiated by Firm May 11, 2022
Create Date June 17, 2022
Recall Status1 Open3, Classified
Recall Number Z-1269-2022
Recall Event ID 90194
PMA Number P190018 
Product Classification intraocular lens - Product Code HQL
Product Alcon Clareon IOL with AutonoMe Delivery System
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
Recalling Firm/
Manufacturer		 Alcon Laboratories Ireland, Ltd
Cork Business And Technology Park
Model Farm Road
Cork Ireland
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 05/11/2022, Alcon Laboratories sent an "URGENT: VOLUNTARY MEDICAL DEVICE REMOVAL" Letter via FedEx overnight informing customer that the firm has initiated a removal of one specific lot (25238769) of the Clareon IOL with AutonoMe Delivery System (CNA0T0.175). Based on the firm's investigation, there is the potential for limited number of 24.0D lenses to be included within this lot of the 17.5D Clareon IOL AutonoMe Delivery System. Customers are asked to locate and return the Alcon 17.5D Clareon IOL AutonoMe Delivery System with lot 25238769. An Alcon associate will reach out to customers directly to arrange for the return and replacement of the affected products. For questions, contact Alcon Customer Service at 1-800-862-5266 or contact their Alcon Sales Representative.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = HQL and Original Applicant = Alcon Laboratories, LLC
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