Fargo Ortho-K Lens

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All Lots, DI - B22208
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
PARAGON VISION SCIENCES, Inc
Reason for Recall:
Manufactured lenses are not covered by existing FDA approval
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Fargo Ortho-K Lens

Product Codes/Lot Numbers:

All Lots, DI - B22208

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2516-2023

Related Recalls

ISee Ortho-K Lens

PARAGON VISION SCIENCES

Class I - Dangerous

Manufactured lenses are not covered by existing FDA approval

Jun 26, 2023 Other Medical Devices Nationwide View Details →