Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-

FDA device recall Z-0939-2026 · posted 2025-12-23 · Open, Classified

Recall details

Recalling firm

Alcon Research LLC

Reason for recall

Ophthalmic procedure packs may have incomplete seals affecting sterility.

Action taken

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.

Root cause

Packaging

Status

Open, Classified

Product code

LRO

Quantity affected

151 units

Distribution

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

Date initiated

2025-11-24

Date posted

2025-12-23

Location

Fort Worth, TX