When FDA issued a warning (classfied the device as "adulterated"), what's consequences? ?

Question

FDA issued a warning that FDA classified the device of a company as "Adulterated". This device is contact lenses. What are implications?

To the patients, for example, the company should notify the patients who wear such lenses?

To the status FDA approval of this product, for example, -- The status of Approval is pending?

To the eye doctor, for example, the doctor should post such warning or notify the patients?

to the company or to FDA, for example, when this "Adulterated" status ends ?

Answer 1

the product should be pulled from the shelves and a recall should be issued.

eye doctors should stop using the product and place signage in their office about the product