Recalls for Eyelid Thermal Pulsation System

Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.

Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.

Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.