FDA recall Z-0939-2026

Alcon Research LLC · Class I · device

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

Reason for recall

Ophthalmic procedure packs may have incomplete seals affecting sterility.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-11-24
Report date
2025-12-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0939-2026