Alcon Clareon IOL with AutonoMe Delivery System
FDA Recall Z-1269-2022 · Posted None
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Recalling FirmAlcon Laboratories Ireland, Ltd
Recall StatusTerminated
Product CodeHQL
Date Initiated2022-05-11
Date Terminated2025-02-05
Product Quantity139 lenses (Lot 25238769) and 164 lenses (Lot 25238775)
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.
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.
Root Cause
Under Investigation by firm
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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