CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
Alcon Laboratories, Inc Accessory devices for Unity recalled
Alcon Research is recalling Alcon Laboratories, Inc Accessory devices for Unity and Constellation surgical consoles, distributed nationwide in the US. The recall was initiated on 5 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0308-2026
- FDA event ID
- 97415
- Recalling firm
- Alcon Research, Fort Worth, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2025
- FDA classified
- 24 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 5 Aug 2025 | Recall initiated by company | |
| 24 Oct 2025 | Classified by FDA | +80 days |
| 5 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to incomplete seals in the pouch which provide the sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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,
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
Due to incomplete seals in the pouch which provide the sterile barrier.
Which lots are affected?
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
Where was it sold?
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,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 97415This product is part of a recall event; the main page for the event is Alcon Laboratories, Inc Accessory devices for Unity recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Alcon Laboratories, Inc Accessory devices for Unity recalled | Alcon Research | Sterility | Nationwide | |
| CLASS II | Alcon Laboratories, Inc Accessory devices for Unity recalled | Alcon Research | Sterility | Nationwide | |
| CLASS II | Alcon Laboratories, Inc Accessory devices for Unity recalled | Alcon Research | Sterility | Nationwide | |
| CLASS II | Alcon Laboratories, Inc Accessory devices for Unity recalled | Alcon Research | Sterility | Nationwide |
More recalls from Alcon Research
All 107| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Systane, Lubricant Eye Gel, Night Gel, Sterile, Processed recalledSystane | Alcon Research | Sterility | Nationwide |
| Drug | CLASS II | GenTeal Tears, Lubricant Eye Gel, Sterile recalled by Alcon ResearchGenteal Tears | Alcon Research | Sterility | Nationwide |
| Device | CLASS I | Alcon Laboratories, Inc Custom Pak recalled by Alcon Research | Alcon Research | Sterility | Nationwide |
| Device | CLASS II | Constellation Ultravit 10K and Constellation Hypervit 20K recalled | Alcon Research | Other | Nationwide |
| Device | CLASS II | Alcon Laboratories, Inc Accessory devices for Unity recalled | Alcon Research | Sterility | Nationwide |
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