Home / Recalls / Alcon Research LLC / Z-0308-2026

Z-0308-2026 Class II Ongoing

Recalled by Alcon Research LLC — Fort Worth, TX

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
1632

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' 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 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: 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

Other recalls by Alcon Research LLC

  • 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-0306-2026 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity (August 5, 2025)
  • Z-0307-2026 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-0304-2026 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)
  • Z-2108-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System (April 28, 2025)
  • Z-2109-2025 Class II — Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System (April 28, 2025)