Alcon Research LLC recalls Brand Name: Alcon Laboratories

Recalling company

Alcon Research LLC

Product

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' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID 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

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 5, 2025

Reported

Nov 5, 2025

Distribution

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,

Status

Ongoing

Quantity

25,778

Lot / codes

Catalog Number: 8065750918 UDI-DI code:00380657509188 Lot/Batch Number: 1790L4 Catalog Number: 8065750957 UDI-DI code: 00380657509577 Lot/Batch Numbers: 1788D3 1788DC 1788D1 1790T0 179LNP 179LNT 179LNV 179LP2 179LPA 17A0P8 17A0PC 17A0PH 17C125 17CJEW 17CXT3 17D0RY 17DL3Y 17DL40 17DL41 17DL42 17DL46 17DPRT 17DPRU 17ERNK 17F2NR 17F55K Catalog Number: 8065750972 UDI-DI code: 00380657509720 Lot/Batch Numbers: 17C8T2 17C8T4 17E0TX Catalog Number: 8065751014 UDI-DI code: 00380657510146 Lot/Batch Numbers: 1789PV 1789PW 1788DD 1788DE 17C2MY 17C2NE 17DL3P 17DL3U 17DL3W 17DL3X 17E0WU 17E0X0 17F4D6 Catalog Number: 8065751441 UDI-DI code: 00380657514410 Lot/Batch Numbers: 17C6U5 17C359 17C35A Catalog Number: 8065751577 UDI-DI code: 00380657515776 Lot/Batch Numbers: 1789P4 1789P5 1789P6 179MCD 17C2RV 17C2RY 17C2T3 17DPN7 17DPN8

Company location

Fort Worth, TX

Recall type

Voluntary: Firm initiated

Recall number

Z-0305-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0305-2026 in the FDA Enforcement Report. Also see FDA recall press releases.