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Indications and Important Safety Information

INDICATIONS AND IMPORTANT SAFETY INFORMATION for TearScience^® LipiFlow^® Thermal Pulsation System

CAUTION

Federal law restricts this device to sale by or on the order of a licensed physician.

INDICATIONS

The TearScience® LipiFlow® Thermal Pulsation 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.

CONTRAINDICATIONS

Do not use the TearScience® 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 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure. Ocular injury within prior 3 months. Ocular herpes of eye or eyelid within prior 3 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 ocular inflammation within prior 3 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).

PRECAUTIONS

The Activator or Activator II (Disposable) may not fit all eyes, such as eyes with small palpebral fornices. Use of the TearScience® 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. 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). Esthetic eyelid and eyelash procedures (e.g., blepharoplasty, lash extensions, eyelid tattooing). In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.

ADVERSE EFFECTS

Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in: Eyelid/eye pain requiring discontinuation of the treatment procedure; Eyelid irritation or inflammation (e.g., edema, bruising, blood blister, 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). 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: Thermal injury to the eyelid or eye, including conjunctiva, cornea or lens; Physical pressure-induced injury to the eyelid; and Ocular surface (corneal) infection.

ATTENTION

Reference the TearScience® LipiFlow® Thermal Pulsation System Instructions for Use for a complete listing of indications, warnings, and precautions.

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