Z-0939-2026Class I

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

Name: Z-0939-2026 Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04...
Creator: Alcon Research LLC
Published: 2025-11-24
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2025-11-24 / Open, Classified / root cause: packaging

FDA source

Alcon Research LLC began a recall of 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... on 2025-11-24. FDA classified it as Class I and gives the reason as "Ophthalmic procedure packs may have incomplete seals affecting sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0939-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-11-24
Posted: 2025-12-23
Recalling firm: Alcon Laboratories
Product: 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
Product code: LRO General Surgery Tray
Reason for recall: Ophthalmic procedure packs may have incomplete seals affecting sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: 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.
Quantity in commerce: 151 units
Distribution: US Nationwide distribution in the states of CA, ND, UT.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0939-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0939-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)