Alcon recalls Clareon IOLs with AutonoMe Delivery System due to mislabeling during manufacturing, which may cause partial product mixing. Affected units have specific catalog/model numbers and lot numbers.
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Alcon is recalling Clareon IOLs with AutonoMe Delivery System because of mislabeling during production, which could lead to partial mixing of the product. This recall affects specific model numbers and lot numbers that were manufactured in certain runs.
The device mislabeling during manufacturing runs could cause partial mixing of the product. This issue is linked to improper clearance between manufacturing lines, but it does not pose a direct risk to patients during normal use.
People who received the Clareon IOL with AutonoMe Delivery System from Alcon Laboratories Ireland, Ltd. Those most at risk are patients who have the specific model numbers and lot numbers listed in the recall.
Check for the catalog/model numbers CNA0T0.175 or CNA0T0.240 and lot numbers 25238769 or 25238775. The recall covers specific units produced in manufacturing runs with these identifiers.
Review the catalog/model number and lot number on your device to confirm if it matches the recalled units.
Alcon recalls these IOLs due to mislabeling during manufacturing, which could cause partial mixing of the product in specific production runs.
Check the catalog/model number and lot number on your device to see if it matches the recalled units. If it does, contact Alcon for further instructions.
The recall is due to a manufacturing issue that may cause partial mixing, but it does not pose a direct risk to patients during normal use.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-1269-2022 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-1269-2022 from Alcon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
