CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report

Alcon Laboratories, Inc Accessory devices for Unity recalled

Alcon Research is recalling Alcon Laboratories, Inc Accessory devices for Unity and Constellation surgical consoles, distributed nationwide in the US. The recall was initiated on 5 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 8065000252 UDI-DI code: 00380650002525 Lot/Batch Numbers: 17CMKR 17D417 Catalog Number: 8065000253 UDI-DI code: 00380650002532 Lot/Batch Number: 17CDMX

Quantity recalled330

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-0307-2026
FDA event ID: 97415
Recalling firm: Alcon Research, Fort Worth, TX
Classification: Class II
Status: Ongoing
Recall initiated: 5 Aug 2025
FDA classified: 24 Oct 2025
Reported: 5 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

5 Aug 2025	Recall initiated by company
24 Oct 2025	Classified by FDA	+80 days
5 Nov 2025	Published in enforcement report	+12 days

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

Reason for recall

Due to incomplete seals in the pouch which provide the sterile barrier.

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: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

Where it was distributed

Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI, and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Is Alcon Laboratories, Inc Accessory devices for Unity and Constellation surgical consoles recalled?

Yes. Alcon Research recalled Alcon Laboratories, Inc Accessory devices for Unity and Constellation surgical consoles on 5 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-0307-2026.

Why was it recalled?

Due to incomplete seals in the pouch which provide the sterile barrier.

Which lots are affected?

Catalog Number: 8065000252 UDI-DI code: 00380650002525 Lot/Batch Numbers: 17CMKR 17D417 Catalog Number: 8065000253 UDI-DI code: 00380650002532 Lot/Batch Number: 17CDMX

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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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