Home / Recalls / Alcon Research LLC / Z-0939-2026

Z-0939-2026 Class I Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

Recall Details

Product Type
Devices
Report Date
December 31, 2025
Initiation Date
November 24, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
151 units

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.

Distribution Pattern

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

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  • Z-0581-2026 Class II — CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ (September 15, 2025)
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  • Z-0307-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0304-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0308-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0305-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-2108-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System (April 28, 2025)
  • Z-2109-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System (April 28, 2025)
  • Z-2110-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Nu (April 28, 2025)