Alcon recalls specific Custom-Pak products with tubing Anti-Reflux Valves that may break due to improper use. Affected units include models from Christiana Care Health Serv, Mercy Hospital, and Illinois Masonic Med Ctr. No remedy is stated in the recall notice.
Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Alcon is recalling certain Custom-Pak products that contain tubing with an Anti-Reflux Valve (ARV) that has reportedly broken due to improper use. This issue was addressed by updating the product labeling, but no specific action is required for users.
The tubing Anti-Reflux Valve (ARV) in these products can break when used improperly, which may lead to complications during eye surgery. However, the recall notes that changes to labeling were made to address this issue, indicating the hazard is not severe under normal use conditions.
Users of the recalled Custom-Pak products, including those from Christiana Care Health Serv, Mercy Hospital, and Illinois Masonic Med Ctr, are likely affected. Patients undergoing eye surgery using these specific models are at the highest risk.
Check for the product model numbers listed in the recall: #15340-11 (Christiana Care Health Serv), #6557-59 and #6557-60 (Mercy Hospital), #9456-59, #9456-60, and #9456-61 (Illinois Masonic Med Ctr), and #12216-12, #12216-14, and #12216-15 (McGee Eye Surg Ctr).
Identify your Custom-Pak model number from the list provided in the recall notice.
The recall is due to reported breakage in the tubing Anti-Reflux Valve (ARV) caused by improper use, which led to changes in product labeling.
No specific action is required as the recall only involves updating labeling to address the issue, not a remedy like repair or replacement.
The products were sold by Christiana Care Health Serv, Mercy Hospital, Illinois Masonic Med Ctr, and McGee Eye Surg Ctr.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-0490-2025 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-0490-2025 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.
