Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203…

Recall date

November 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0939-2026

FDA classification

Class I

Brand / firm

Alcon Research LLC

Sold / distributed

US Nationwide distribution in the states of CA, ND, UT.

Why it was recalled

Ophthalmic procedure packs may have incomplete seals affecting sterility.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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