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Lower risk Medical device recall · FDA · Published August 5, 2025

Alcon Accessory Devices Recall: Incomplete Sterile Pouch Seals Risk Contamination

Alcon recalls accessory devices for Unity and Constellation surgical consoles due to incomplete sterile pouch seals that could lead to contamination during vitrectomy procedures. Affected models include specific catalog numbers and batch numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0305-2026Medical deviceAlcon Laboratories ›
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Contact the company

Recalling firmAlcon Research LLC6201 South Fwy · Fort Worth, TX 76134-2099
✎ GovInfoNow plain-language explainer

Alcon is recalling accessory devices for Unity and Constellation surgical consoles because the pouches that keep them sterile have incomplete seals. This could lead to contamination during eye surgery if the devices are used without proper sterilization. Read more at govinfonow.com/recall/51679-alcon-accessory-devices-recall-incomplete-sterile-pouch-seals-risk-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/51679-alcon-accessory-devices-recall-incomplete-sterile-pouch-seals-risk-contamination · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0305-2026

Cite this page

“Alcon Accessory Devices Recall: Incomplete Sterile Pouch Seals Risk Contamination.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51679-alcon-accessory-devices-recall-incomplete-sterile-pouch-seals-risk-contamination. Based on FDA recall #Z-0305-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0305-2026%22&limit=1).

The FDA announced on 2025-08-05 that Alcon Research LLC is recalling accessory devices for Unity and Constellation surgical consoles due to incomplete seals in the sterile barrier pouches. The recall affects 25,778 units distributed worldwide.

How to tell if you have it

  • Brand: Alcon Laboratories
  • Product: Accessory devices for Unity and Constellation surgical consoles
  • Catalog Number: 8065750918, Lot/Batch Number: 1790L4
  • Catalog Number: 8065750957, 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, Lot/Batch Numbers: 17C8T2, 17C8T4, 17E0TX
  • Catalog Number: 8065751014, Lot/Batch Numbers: 1789PV, 1789PW, 1788DD, 1788DE, 17C2MY, 17C2NE, 17DL3P, 17DL3U, 17DL3W, 17DL3X, 17E0WU, 17E0X0, 17F4D6
  • Catalog Number: 8065751441, Lot/Batch Numbers: 17C6U5, 17C359, 17C35A
  • Catalog Number: 8065751577, Lot/Batch Numbers: 1789P4, 1789P5, 1789P6, 179MCD, 17C2RV, 17C2RY, 17C2T3, 17DPN7, 17DPN8

The hazard

The recall is due to incomplete seals in the pouch which provide the sterile barrier. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Alcon Research LLC has 24 other recalls on record since 2018-07-25. Other recent recalls of similar products include Alcon GenTeal Tears Eye Gel Recall (2026-04-21), Alcon Custom Pak Sterility Risk (2025-11-24), and Alcon Recalls PRECISION1 Contact Lenses Due to Sterility Risk (2025-09-30). Other recent recalls of similar products include Covidien V-Loc 90 Wound Closure Device Recall (2026-06-24), Intuitive Surgical Ion Vision Probe Bag Recall (2025-12-04), and Covidien V-Loc 180 Absorbable Wound Closure Device Recall (2026-06-24).

How to tell if you have this one

Check the catalog number on the device, which includes numbers like 8065750918, 8065750957, and others listed in the recall notice. Also look for batch numbers such as 1790L4 or 1788D3.

  • Brand
    Alcon Laboratories
  • Category
    Medical device
FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • 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,
Recall numberProduct, codes & lotsQuantity
Z-0304-2026Brand 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; 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: 17E33N577
Z-0305-2026Brand 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; 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 17DPN825,778
Z-0306-2026Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK 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; Catalog Number: 8065000393 UDI-DI code: 00380650003935 Lot/Batch Number: 17CDKX6
Z-0307-2026Brand 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; Catalog Number: 8065000252 UDI-DI code: 00380650002525 Lot/Batch Numbers: 17CMKR 17D417 Catalog Number: 8065000253 UDI-DI code: 00380650002532 Lot/Batch Number: 17CDMX330
Z-0308-2026Brand 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; 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: 17CP3U1632
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Identify the catalog number and batch numbers listed in the recall notice to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 45 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Aug 5, 202512. FDA classified it Class II: Oct 24, 202523. Published in FDA’s Enforcement Report: Nov 5, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0305-2026 (August 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0305-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA