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U.S. Department of Health and Human Services

Class 1 Device Recall Alcon Laboratories, Inc.

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 Class 1 Device Recall Alcon Laboratories, Inc.see related information
Date Initiated by FirmNovember 24, 2025
Date PostedDecember 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0939-2026
Recall Event ID 98055
Product Classification General surgery tray - Product Code LRO
ProductBrand 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
Code Information 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
Recalling Firm/
Manufacturer		 Alcon Research LLC
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information ContactDale Schaper
1-817-5686421
Manufacturer Reason
for Recall		Ophthalmic procedure packs may have incomplete seals affecting sterility.
FDA Determined
Cause 2		Packaging
ActionOn 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.
Quantity in Commerce151 units
DistributionUS Nationwide distribution in the states of CA, ND, UT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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