Patient Safety Information
The LipiFlow® System is used by your doctor 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 eyes or lipid deficiency dry eye.
The LipiFlow® System is a prescription device. Federal law restricts the device to sale by or on the order of a licensed doctor.
You are not a candidate for LipiFlow® if you have experienced any of the following conditions within the last 3 months: eye surgery; eye injury; Herpes of the eye or eyelid; or history of chronic eye inflammation. You are also not a candidate if you have an active eye infection, eye inflammation, eyelid irregularity or eye surface irregularity.
Tell your doctor if you have a history of eye allergies, eyelid inflammation, systemic disease that causes dry eye, or are taking medications known to cause dryness. The device may not fit all eyes, such as small eyelid anatomy. In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen dry eye symptoms.
Possible adverse events that may occur as a result of the treatment procedure include, but are not limited to the onset of or increase in: eyelid or eye pain requiring discontinuation of the treatment procedure; redness and/or swelling of the eyelid or eye surface; irritation of the eye surface; inflammation of the glands in the eyelid, stye in the eyelid, slight worsening of eyelid gland blockage; and eye symptoms of dryness, redness, burning sensation, stinging, tearing, itching, discharge, foreign body or sticky sensation, eye fatigue, hazy or blurred vision, and sensitivity to light. Potential serious adverse events that are not anticipated because the device is designed to prevent occurrence include thermal injury of the eye or eyelid; physical pressure-induced injury to the eyelid; and eye surface infection.
The LipiFlow® Ocular Surface Interferometer is an eye imaging device used by your doctor in adult patients to take digital pictures or images of the tears on the surface of the eye, known as the tear film. The images show a color pattern from light reflected off of the tear film, called specular (interferometric) observations. Using the LipiFlow® Interferometer, your doctor can view, monitor, manipulate, store and document the tear film images.
The LipiFlow® Interferometer is a prescription device. Federal law restricts the device to sale by or on the order of a licensed doctor.
Prior to taking images of your tear film, advise your doctor if you have used eye drops recently; worn contact lenses; used oil-based cosmetics around your eye; rubbed your eye; recently swam in a chlorinated pool, or are aware of any condition that affects your eye surface and the stability of your tears. These conditions may affect the imaging assessment of your tear film.
