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 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.
The Custom Pak surgical packs may have incomplete seals, compromising sterility. Using a non-sterile surgical pack can lead to serious infections during procedures.
No specific incidents have been reported by the company. The recall is classified as Class I, indicating a high risk of serious injury.
Stop using the Custom Pak surgical packs immediately. Follow recall instructions provided in a notification letter from Alcon. Contact Alcon Research LLC or your healthcare provider for further instructions.
For assistance, contact Alcon Research LLC at 1-800-XXX-XXXX or visit their website for more information.
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