Alcon Research LLC has recalled approximately 230 units of the Surgical Image Guidance software (version 1.5) used with the NGENUITY 3D Visualization System. A software anomaly can cause the system to incorrectly calculate eye registration angles if the eye moves significantly during surgery, leading to the wrong placement of toric intraocular lenses. This defect can cause astigmatic errors and decreased vision quality for patients following surgery. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding this software issue.
The software may display incorrect range indicators and alignment data during eye surgery. This leads to the physical misplacement of corrective lenses within the eye, which can result in under-correction or over-correction of astigmatism and permanently blurred or decreased vision.
Manufacturer correction/update
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.
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 · 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.