Home / Recalls / Alcon Research LLC / Z-0304-2026

Z-0304-2026 Class II Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

FDA device recall Z-0304-2026 was initiated by Alcon Research LLC on August 5, 2025 and is designated Class II. Reason for recall: Due to incomplete seals in the pouch which provide the sterile barrier. The recall status is ongoing. Affected quantity: 577.

Recall Details

Product Type: Devices
Report Date: November 5, 2025
Initiation Date: August 5, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 577

Product Description

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' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT 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

Reason for Recall

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

Distribution Pattern

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,

Code Information

Catalog Number: 8065000250 UDI-DI code: 00380650002501 Lot/Batch Numbers: 17E6P1 17E77V Catalog Number: 8065753168 UDI-DI code: 00380657531684 Lot/Batch Number: 17EKTW Catalog Number: 8065753179 UDI-DI code: 00380657531790 Lot/Batch Number: 17E33N

Other recalls by Alcon Research LLC

D-0492-2026 Class II — GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alc (April 21, 2026)
D-0491-2026 Class II — Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in Fran (April 21, 2026)
Z-0939-2026 Class I — Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Nu (November 24, 2025)
Z-0326-2026 Class II — Alcon PRECISION1 One-Day Contact Lenses, -2.25D. (September 30, 2025)
Z-0581-2026 Class II — CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ (September 15, 2025)
Z-0307-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
Z-0308-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
Z-0305-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
Z-0306-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
Z-2110-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Nu (April 28, 2025)