Labeling and Safety

LipiView® Labeling and Risks:


Indications for Use

The LipiView® 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, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer.

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 LipiView® Interferometer.

Precautions

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

  • Use of ophthalmic drops such as artificial tear lubricants, ointments, and medications. Do not instill oil-based ophthalmic drops (e.g., Soothe®, Restasis®) 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 4 hours after the instillation of all other ophthalmic drops prior to device use.
  • Soft or rigid contact lens wear. Remove contact lenses at least 4 hours prior to device use.
  • Use of oil-based facial cosmetics around the eye.
  • Eye rubbing.
  • Recent swimming in a chlorinated pool. Do 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 the LipiView®.

The LipiView® Interferometer does not physically touch the eye. Light exposure is at safe levels for observation of the tear film and image capture.

LipiFlow® Labeling and Risks:


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 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:

  • 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).

Potential serious adverse events 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 infection.