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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Alcon Research, LLC: Constellation Vision Systems Recalled for Potential Loss of Pressure Control

Agency Publication Date: October 11, 2023
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Summary

Alcon Research, LLC has recalled three units of the Constellation Vision System (Model REF: 8065751150) used in ophthalmic microsurgeries. A new circuit board design can cause electrical components to receive too much voltage and fail, which leads to a sudden loss of pressure control for surgical tools like cutters, scissors, and forceps. This recall affects devices in Georgia, Illinois, and Puerto Rico. Because this failure can occur during delicate eye surgery, the manufacturer is conducting on-site visits to address the issue. Patients or providers should contact the manufacturer or their healthcare provider for further instructions.

Risk

The failure of the circuit board can cause a sudden loss of control over pressurized surgical instruments. This malfunction increases the risk of microbial infection, accidental tissue damage, and progressive visual impairment during eye surgery.

What You Should Do

  1. Identify if your surgical facility uses the Constellation Vision System, specifically Model REF: 8065751150.
  2. Check the serial numbers on your devices to see if they match the three affected units: 1403028701X, 1202865201X, or 0802983301X.
  3. If you have an affected unit, contact Alcon Research, LLC at 15800 Alton Pkwy, Irvine, California, 92618-3818, to coordinate a service visit.
  4. Healthcare providers should contact their manufacturer representative to verify if a Printed Circuit Board (PCB) update or replacement is required for their specific unit.
  5. For further information or to report concerns, contact your healthcare provider or Alcon Research, LLC.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated on-site visit to address circuit board failure.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential remedy.

Affected Products

Product: Constellation Vision System (REF: 8065751150)
Model / REF:
REF: 8065751150
UDI-DI: 00380657511501
Lot Numbers:
1403028701X
1202865201X
0802983301X

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93010
Status: Active
Manufacturer: Alcon Research, LLC
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 3
Distributed To: Georgia, Illinois, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.