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Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 1920
Recalled December 31, 2025 · FDA recall Z-0939-2026 · Alcon Research
Hazard
Ophthalmic procedure packs may have incomplete seals affecting sterility. · FDA Class I
Units
151 units
Sold at
US Nationwide distribution in the states of CA, ND, UT.
Description
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Product
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
Manufacturer(s)
Alcon Research LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →