Z-1269-2022Class II

Alcon Clareon IOL with AutonoMe Delivery System

Name: Z-1269-2022 Alcon Clareon IOL with AutonoMe Delivery System
Creator: Alcon Laboratories Ireland, Ltd
Published: 2022-05-11
License: https://open.fda.gov/license/

Alcon Laboratories Ireland, Ltd / initiated 2022-05-11 / Terminated / root cause: labeling and UDI

FDA source

Alcon Laboratories Ireland, Ltd began a recall of Alcon Clareon IOL with AutonoMe Delivery System on 2022-05-11. FDA classified it as Class II and gives the reason as "Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1269-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-11
Posted: 2022-06-17
Terminated: 2025-02-05
Recalling firm: Alcon Laboratories Ireland, Ltd
Product: Alcon Clareon IOL with AutonoMe Delivery System
Product code: HQL Intraocular Lens
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.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1269-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1269-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-29	2022-06-17

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)