Use cautionMedical device recall · FDA · Published August 18, 2023
Alcon Constellation Vision System Recall: Risk of Infection from PCB Design Flaw
Alcon recalls Constellation Vision System (REF: 8065751150) due to a PCB design flaw that may cause loss of pressure control, increasing infection risk. Affected units have specific serial numbers.
Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.
Take action
Contact the company
📍Recalling firmAlcon Research, LLC15800 Alton Pkwy · Irvine, CA 92618-3818
“Alcon Constellation Vision System Recall: Risk of Infection from PCB Design Flaw.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/57463-alcon-constellation-vision-system-recall-risk-of-infection-from-pcb. Based on FDA recall #Z-0099-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0099-2024%22&limit=1).
The FDA announced on August 18, 2023, that Alcon Research LLC is recalling the Constellation Vision System (REF: 8065751150) due to a potential loss of pressure control. This defect could lead to microbial infection, tissue damage, and progressive visual impairment.
How to tell if you have it
Brand: Alcon
Product: Constellation Vision System
REF: 8065751150
UDI-DI: 00380657511501
Serial Numbers: 1403028701X, 1202865201X, 0802983301X
The hazard
According to the FDA, the ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component. This could cause component failure and loss of pressure control for cutters, scissors, and forceps, increasing the risk of microbial infection, tissue damage, and progressive visual impairment.
Context
GovInfoNow's records show Alcon Research LLC has 24 other recalls on record since July 25, 2018. Recent similar recalls include the Alcon GenTeal Tears Eye Gel Recall (April 21, 2026) and the Alcon Custom Pak Sterility Risk recall (November 24, 2025). Other recent recalls of similar products include the Covidien V-Loc 90 Wound Closure Device Recall (June 24, 2026), the Canon Alphenix X-ray Systems Recall (August 4, 2026), and the Canon Alphenix INFX-8000F X-Ray System Recall (December 19, 2025).
How to tell if you have this one
Check for serial numbers: 1403028701X, 1202865201X, or 0802983301X. The product was sold with the reference number REF: 8065751150.
Brand
Alcon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Look for serial numbers 1403028701X, 1202865201X, or 0802983301X on the device.
Where it went and when
Where it was distributed
Distributed in Georgia, Illinois and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “US: GA, IL, PR” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia, Illinois, Puerto Rico.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0099-2024 (August 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0099-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.