FDA-Device2025-12-31Class IPACKAGING DEFECT
Alcon Custom Pak ophthalmic surgical packs recalled for incomplete sterility seals
Nationwide distribution
Stop using affected Alcon Custom Pak surgical packs
Alcon Custom Pak sterile surgical procedure packs used in eye surgery may have incomplete seals that could compromise sterility. This affects 151 units across specific lot numbers. No injuries have been reported.
- Check your inventory for Custom Pak units with lot numbers 17PJ9X, 17PJAY, 17PU09, 17PMWE, 17PTXP, or 17PTXY
- Do not use affected packs for surgical procedures
- Contact Alcon Research LLC for instructions on replacement or return
Hazard
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Sold states
US Nationwide distribution in the states of CA, ND, UT.
Affected count
151 units
Manufactured in
6201 South Fwy, N/A, Fort Worth, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0939-2026Don't want to check this manually?
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