FDA Device Recall Z-0939-2026: Alcon Research LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0939-2026.

Recall Res Number

Z-0939-2026

Recalling Firm / Manufacturer

Alcon Research LLC

FEI Number

1610287

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2025-11-24

Date Posted

2025-12-23

Date Terminated

N/A

Product Code

LRO

Event Number

98055

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.

Action Details On November 24, 2025, Alcon issued a Urgent Medical Device Notification to affected consignees. Alcon ask affected consignees to take the following actions: 1. Review your inventory to determine if you have any unused affected product within your facility. 2. Segregate and dispose of any unused affected product from your inventory. 3. Call Alcon Customer Service to arrange for replacement of your affected inventory of Alcon Custom Pak. 4. Respond to Alcon indicating your understanding of these instructions. 5. Please forward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred.

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

Code Information / Serial Numbers 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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Medical Device Recall: Z-0939-2026

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer