Lower riskMedical device recall · FDA · Published July 25, 2018
Alcon Constellation Vision System 20 GA Totalplus Pak Recall: Wrong Cannula Risk
Alcon recalls 20 GA Totalplus Procedure Pak (Product #8065751079) due to possible inclusion of 25-gauge cannula instead of 20-gauge, which could cause incorrect surgical procedures.
“Alcon Constellation Vision System 20 GA Totalplus Pak Recall: Wrong Cannula Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70291-alcon-constellation-vision-system-20-ga-totalplus-pak-recall-wrong. Based on FDA recall #Z-1794-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1794-2020%22&limit=1).
Alcon Research LLC recalled one Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak due to a potential wrong cannula gauge, according to the FDA on July 25, 2018.
How to tell if you have it
Brand: Alcon
Product: Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak
Product #: 8065751079
Lot #: 2128524H
The hazard
The recall addresses the potential inclusion of a 25-gauge infusion cannula within the procedure pak instead of the specified 20-gauge infusion cannula, according to the FDA.
Context
GovInfoNow's records show Alcon Research LLC has issued 24 other recalls since April 17, 2020. Other recent recalls include an Alcon GenTeal Tears Eye Gel recall for lack of sterility assurance on April 21, 2026, and an Alcon Custom Pak sterility risk recall on November 24, 2025. Similar product recalls include a Vortex Surgical 25GA Subretinal Injection Cannula recall on December 16, 2025, and Medtronic EOPA Arterial Cannula and Perfusion Systems EOPA Cannula recalls on June 24, 2026.
How to tell if you have this one
Check for the product number 8065751079 on the label. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. The lot number is 2128524H.
Brand
Alcon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the product number 8065751079 and lot number 2128524H on the label.
How this recall unfolded
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3FDA terminated the recall
4Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall indicates a potential risk of using the wrong cannula size, but the product is not unsafe if the correct cannula is used. The manufacturer has not provided a fix.
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-1794-2020 (July 25, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1794-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.