Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Surgical Image Guidance Functionality Recalled by Alcon Research LLC Due to After surgery initiation, while using surgical image guidance,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research LLC directly.
Affected Products
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Quantity: 230
Why Was This Recalled?
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alcon Research LLC
Alcon Research LLC has 59 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report