Product & Safety Labeling

LIPIFLOW® Thermal Pulsation System

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.

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 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 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.

Potential 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)

  • 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

  • Ocular surface (corneal) infection

LipiView® II Ocular Surface Interferometer

Indications for Use

The LipiView II Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of:

  • Specular (interferometric) observations of the tear film. Using these images, LipiView II measures the absolute thickness of the tear film lipid layer.

  • Meibomian glands under near-infrared (NIR) illumination.

  • The ocular surface and eyelids under white illumination.

CONTRAINDICATIONS

Contraindications are conditions in which the device should not be used because the risk of use clearly outweighs any benefit. No contraindications have been identified for LipiView II.

Precautions

The following patient conditions may affect the interferometry assessment of a patient’s tear film using LipiView II:

  • Use of ophthalmic drops such as artificial tear lubricants, ointments, and medications. Advise patients not not instill oil-based ophthalmic drops (e.g., Soothe ®, Restasis®, Systane Balance®) for at least 12 hours prior to device use and not to instill ointments for at least 24 hours prior to device use. Wait at least four (4) hours after the instillation of all other ophthalmic drops prior to device use.

  • Soft or rigid contact lens wear. Advise patients to remove contact lenses at least four hours prior to device use.

  • Use of oil-based facial cosmetics around the eye.

  • Eye rubbing.

  • Recent swimming in a chlorinated pool. Advise pateints to not to swim for at least 12 hours prior to device use.

  • Any ocular surface condition that affects the stability of the tear film. These conditions include disease, dystrophy, trauma, scarring, surgery, or abnormality.

Potential Adverse Effects

There are no known or anticipated adverse effects associated with use of this device.

LipiScan Dynamic Meibomian Imager

Indications for Use

LipiScan Dynamic Meibomian Imager (DMI) is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.

Contraindications

Contraindications are conditions in which the device should not be used because the risk of use clearly outweighs any benefit.

No contraindications have been identified for the LipiScan

Precautions

Precautions provide information regarding any special care to be exercised by the practitioner for the safe and effective use of the device, as described below. Caution: Disinfect the surfaces of the chin rest, forehead rest and Handheld Near Infrared (IR) Lid Everter with isopropyl alcohol immediately prior to use and prior to storage to prevent cross-contamination and patient infection.

Potential Adverse Effects

There are no known or anticipated adverse effects associated with use of this device.

Meibomian Gland Evaluator (MGE)

Indications for Use

The Meibomian Gland Evaluator is a hand held instrument used by a physician to evaluate Meibomian gland secretions in adult patients during a routine eye examination. The instrument provides a standardized method to apply consistent, gentle pressure to the outer skin of the lower eyelid while visualizing the secretions from the Meibomian gland orifices through a slit lamp biomicroscope.

Contraindications

No contraindications are known.

Precautions

  • Do not depress the shaft to the endpoint of the spring. Do not apply any additional force after the shaft has been depressed approximately 6 mm. Applying additional force negates the benefit of using the instrument to apply standard force.

  • Familiarity with use of a slit lamp biomicroscope is required to use Meibomian Gland Evaluator for assessment of the meibomian gland secretions.

Potential Adverse Effects

Potential adverse effects that are unlikely but may occur with use of the Meibomian Gland Evaluator include but are not limited to:

  • Skin abrasion (e.g., from a rough surface on the device)

  • Eye abrasion (e.g., from improper contact of the instrument with the eye)

  • Infection of the skin or eye (e.g., from improper or lack of disinfection after use and between patients)

  • Allergic or toxic reaction (e.g., from exposure to any residue on device during user handling)