Recall Z-2515-2023— PARAGON VISION SCIENCES, Inc

Name: FDA recall Z-2515-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-26

Class II · Ongoing

Class II FDA medical device recall by PARAGON VISION SCIENCES, Inc, initiated 2023-06-26. FDA's recall record names no specific 510(k) clearance for this event. Product: ISee Ortho-K Lens. Reason: Manufactured lenses are not covered by existing FDA approval.

Recalling firm: PARAGON VISION SCIENCES, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-06-26
Firm location: Gilbert, AZ, United States

Product description

ISee Ortho-K Lens

Reason for recall

Manufactured lenses are not covered by existing FDA approval

Data sourced from openFDA. This site is unofficial and independent of the FDA.