Clareon recallZ-1269-2022 · Alcon Laboratories Ireland, Ltd · initiated May 11, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alcon Laboratories Ireland, Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1269-2022
- Status
- Terminated
- Initiated by the company
- May 11, 2022
- Recalling firm
- Alcon Laboratories Ireland, Ltd
- Quantity
- 139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
- Product code
- HQL
- FDA submissions
- P190018
- 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
Product description
Alcon Clareon IOL with AutonoMe Delivery System
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall27 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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