Medical Device Recall: Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Cu
Alcon Research LLC · November 24, 2025
Reason for Recall
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Product Description
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
Distribution
US Nationwide distribution in the states of CA, ND, UT.
States Affected
NATIONWIDE
Quantity Affected
151 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0939-2026
Status: ongoing
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