Eyeworld

200K TREATMENTS WORLDWIDE & GROWING 2 5 PROSPECTIVE RANDOMIZED & CONTROLLED TRIALS 3, 4, 5, 6, 7 30 + PEER-REVIEWED REPORTS 1, 3, 4, 5, 6, 7 10 + YEARS OF RESEARCH 8 LipiFlow® removes obstruction by treating MGD from the inner lid. 1, 2 PROVEN TREATMENT FOR MGD Visit jnjvisionpro.com/products/ocular-surface-care for more information References: 1. Blackie CA, Carlson AN, Korb, DR. Treatment for meibomian gland dysfunction and dry eye symptoms with a single-dose vectored thermal pulsation: a review. Curr Opin in Ophthalmol. 2015; 26(4): 306-13. 2. LipiFlow® Thermal Pulsation Instructions For Use. 3. Blackie CA, Coleman CA, Holland EJ. The sustained eŒ ect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye. Clin Ophthalmol. 2016; 10: 1385-1396. 4. Finis D, et al. Six-month eŒ ects of a thermodynamic treatment (LipiFlow®) systems for MGD and implications of meibomian gland atrophy. Cornea. 2014, 33(12): 1265-1270. 5. Lane SS, Dubiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction. Cornea. 2012; 31(4): 396. 6. Blackie CA, Coleman CA, et al. A single vectored thermal pulsation treatment for meibomian gland dysfunction, increases mean comfortable contact lens wearing time by approximately 4 hours per day. Clin Ophthalmol. 2018 Jan; 12: 169-183. 7. Hagen KB, Bedi R, Blackie CA and Christenson-Akagi K. Comparison pf a single-dose vectored thermal pulsation procedure with a 3-month course of daily oral doxycycline for moderate- to-severe meibomian gland dysfunction. Clin Ophthalmol. 2018; 12:161-168. 8. Data on fi le. LipiFlow is a trademark of TearScience, Inc. © TearScience, Inc. 2019 PP2019TS4175 INDICATIONS AND IMPORTANT SAFETY INFORMATION for LipiFlow® Thermal Pulsation System INDICATIONS The 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 defi ciency dry eye. CONTRAINDICATIONS 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 eŒ ectiveness 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 infl ammation or history of chronic, recurrent ocular infl ammation within prior 3 months (e.g., retinitis, macular infl ammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis) • Eyelid abnormalities that a„ ect 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 fl uorescein staining, or map dot fi ngerprint dystrophy) PRECAUTIONS The Activator or Activator II (Disposable) may not fi t 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 eŒ ectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and eŒ ectiveness 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 infl ammation (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis). Patients with severe eyelid infl ammation should be treated medically prior to device use. • Systemic disease conditions that cause dry eye (e.g., Stevens- Johnson syndrome, vitamin A defi ciency, 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 eŒ ects 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 infl ammation (e.g., edema, bruising, blood blister, dermatitis, hordeolum or chalazion); • Ocular surface irritation or infl ammation (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 (defi ned 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 LipiFlow® Thermal Pulsation System Instructions for Use for a complete listing of indications, warnings, and precautions. Ocular health starts at the surface

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