The LipiFlow® System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including Meibomian Gland Dysfunction (MGD), also known as Evaporative Dry Eye or Lipid Deficiency Dry Eye.
Do not use the LipiFlow® System in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.
The Activator or Activator II (Disposable) may not fit all eyes, such as eyes with small palpebral fornices.
Use of the LipiFlow® System in patients with the following conditions may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and effectiveness of the device have not been studied in patients with these conditions.
In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.
In the randomized, controlled clinical study, there were no serious adverse events related to the use of the LipiFlow® System. The non-serious device-related adverse events for the LipiFlow® System included moderate eyelid pain and moderate conjunctival hyperemia or vascular injection. Other slit lamp findings included eyelid hyperemia, eyelid edema, conjunctival petechial hemorrhages, conjunctival chemosis or edema, superficial punctate epithelial keratopathy, ocular surface staining, and discharge or mucus in the tear film. These non-serious adverse events and slit lamp findings were temporary and resolved during the four-week study without any permanent effect or need for medical treatment.
Potential serious adverse events (defined as permanent impairment or damage to a body structure or function or necessitates medical or surgical intervention to preclude permanent impairment or damage to a body structure or function) that are not anticipated because of the device mitigations to prevent occurrence include: