PARAGON VISION SCIENCES, Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ISee Ortho-K LensClass IIJun 26, 2023Manufactured lenses are not covered by existing FDA approval	Manufactured lenses are not covered by existing FDA approval	Class IIDevices	Jun 26, 2023
Fargo Ortho-K LensClass IIJun 26, 2023Manufactured lenses are not covered by existing FDA approval	Manufactured lenses are not covered by existing FDA approval	Class IIDevices	Jun 26, 2023