CLASS I ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report

Alcon Laboratories, Inc Custom Pak recalled by Alcon Research

Alcon Research is recalling Alcon Laboratories, Inc Custom Pak, distributed nationwide in the US. The recall was initiated on 24 Nov 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI: *+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 recalled151 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0939-2026
FDA event ID: 98055
Recalling firm: Alcon Research, Fort Worth, TX
Classification: Class I
Status: Ongoing
Recall initiated: 24 Nov 2025
FDA classified: 23 Dec 2025
Reported: 31 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

24 Nov 2025	Recall initiated by company
23 Dec 2025	Classified by FDA	+29 days
31 Dec 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ophthalmic procedure packs may have incomplete seals affecting sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California North Dakota Utah

Questions about this recall

Is Alcon Laboratories, Inc Custom Pak recalled?

Yes. Alcon Research recalled Alcon Laboratories, Inc Custom Pak on 24 Nov 2025. The recall is Class I and its status is Ongoing. Recall number Z-0939-2026.

Why was it recalled?

Ophthalmic procedure packs may have incomplete seals affecting sterility.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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