Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 1920
Summary
The FDA issued a Class I for Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Nu by Alcon Research LLC. Reason: Ophthalmic procedure packs may have incomplete seals affecting sterility..
Details
Source
Device Recall
External ID
Z-0939-2026
Action Date
2025-12-31
Status
Ongoing
Category
device
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
Lot/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
Quantity Affected: 151 units
Reason for Recall
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Distribution
US Nationwide distribution in the states of CA, ND, UT.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-24
Company
Fort Worth, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 103 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Alcon Research LLC has 66 FDA actions in our database, including 66 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alcon Research LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alcon Research LLC have FDA actions?
Alcon Research LLC has 66 FDA actions in our database, including 66 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0939-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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