PARAGON VISION SCIENCES, Inc. is recalling 102,362 ISee and Fargo Ortho-K contact lenses because they were manufactured and distributed without the necessary FDA approval. This recall affects 83,542 ISee lenses and 18,820 Fargo lenses. These specific lenses are not covered under any existing regulatory clearance, meaning their safety and effectiveness have not been validated for consumer use. Consumers who have purchased these lenses should contact their eye care professional or the manufacturer immediately.
The use of medical devices that lack FDA approval means the manufacturing standards and clinical performance have not been reviewed for safety. Using unapproved contact lenses may pose a risk of eye irritation, infection, or other vision-related complications as the product's safety profile is unknown.
Professional consultation and manufacturer contact
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.