Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 1...
FDA Recall #Z-0939-2026 — Class I — November 24, 2025
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
Reason for Recall
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Recalling Firm
Alcon Research LLC — Fort Worth, TX
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
151 units
Distribution
US Nationwide distribution in the states of CA, ND, UT.
Code Information
UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X, 17188-04 - Lot # 17PJAY, 19762-03 - Lot # 17PU09, 19203-04- Lot # 17PMWE, 19203-04 - Lot # 17PTXP, 17957-10- Lot #17PTXY
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated