Indications for Use
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.
- Ocular surgery within prior three months, including intraocular, oculo-plastic, corneal or refractive surgery procedure
- Ocular injury within prior three months
- Ocular Herpes of eye or eyelid within prior three months
- Active ocular infection e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye
- Active ocular inflammation or history of chronic, recurrent ocularinflammation within prior three months e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis
- Eyelid abnormalities that affect lid function e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis
- Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy
The Disposable may not fit all eyes, such as eyes with small palpebral fornices. Use of the LipiFlow® System is not recommended in patients with the following conditions. Patients with these conditions may have reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands. Safety and effectiveness of the device have not been studied in patients with these conditions.
- Moderate to severe (Grade 2-4) allergic, vernal, or giant papillary conjunctivitis
- Severe (Grade 3 or 4) eyelid inflammation e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis. Patients with severe eyelid inflammation should be treated medically prior to device use.
- Systemic disease conditions that cause dry eye e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener’s granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjögren’s syndrome
- Taking medications known to cause dryness e.g., isotretinoin (Accutane®), and systemic antihistamines
In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.
Potential Adverse Effects
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 adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in
Potential serious adverse events that are not anticipated because of the device mitigations to prevent occurrence include:
- Eyelid/eye pain requiring discontinuation of the treatment procedure
- Eyelid irritation or inflammation e.g., edema, dermatitis, hordeolum or chalazion
- Ocular surface irritation or inflammation e.g., corneal abrasion, conjunctival edema or conjunctival injection (hyperemia); and
- Ocular symptoms e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light
- Thermal injury to the eyelid or eye, including conjunctiva, cornea or lens;
- Physical pressure-induced injury to the eyelid;
- Ocular surface infection.