WhichRecall
Class I — UrgentReported 2025-12-31

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

Recalled by Alcon Research LLC

Reason for Recall

Ophthalmic procedure packs may have incomplete seals affecting sterility.

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Recall Number
Z-0939-2026
Classification
Class I
Status
Ongoing
Category
device
Initiated
2025-11-24
Reported
2025-12-31
Distribution
US Nationwide distribution in the states of CA, ND, UT.
Code Info
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
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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