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' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 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

1632

Lot / codes

Catalog Number: 8065000356 UDI-DI code: 00380650003560 Lot/Batch Numbers: 17CFND Catalog Number: 8065000358 UDI-DI code: 00380650003584 Lot/Batch Numbers: 17CMKW 17DR9L Catalog Number: 8065000359 UDI-DI code: 00380650003591 Lot/Batch Number: 17DWCY Catalog Number: 8065000467 UDI-DI code: 00380650004673 Lot/Batch Number: 17CP3T Catalog Number: 8065000468 UDI-DI code: 00380650004680 Lot/Batch Number: 17CP3U

Company location

Fort Worth, TX

Recall type

Voluntary: Firm initiated

Recall number

Z-0308-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0308-2026 in the FDA Enforcement Report. Also see FDA recall press releases.