Alcon Laboratories, Inc. recalled 151 units of Custom Pak surgical procedure packs on November 24, 2025. The recall stems from incomplete seals that may affect sterility. Healthcare providers and patients should stop using the products immediately.
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Alcon Research LLC or your healthcare provider for instructions. Notification method: Letter
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The Alcon Custom Pak surgical packs are designed for ophthalmic surgeries, containing various instruments and materials needed for the procedures. Surgeons rely on their sterility to prevent infection during surgeries.
Incomplete seals on the packs compromise their sterility, increasing the risk of infections during surgical procedures. This poses a significant health risk to patients undergoing surgery.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act quickly to ensure they do not use compromised surgical packs, which could lead to serious health complications.
Model numbers can typically be found on the packaging or inside the product's instruction manual.
Expect refund processing to take 4-6 weeks after returning the affected packs.
Keep records of your purchase, including receipts, and document any communication with Alcon regarding the recall.
The recalled models include 9903-20, 17188-04, 19762-03, 19203-04, and 17957-10. These packs were distributed nationwide in California, North Dakota, and Utah. The products are designed for use in various ophthalmic surgeries.
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