INDICATIONS AND IMPORTANT SAFETY INFORMATION for LIPIFLOW® Thermal Pulsation System

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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 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
• • Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
• • Eyelid abnormalities that affect lid function
• • Ocular surface abnormality that may compromise corneal integrity

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. Patients with severe eyelid inflammation should be treated medically prior to device use.
• • Systemic disease conditions that cause dry eye
• • Taking medications known to cause dryness
• • Esthetic eyelid and eyelash procedures

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;
• • Ocular surface irritation or inflammation; 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 LipiFlow Thermal Pulsation System Instructions for Use for a complete listing of indications, warnings, and precautions.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for LIPIVIEW® II Ocular Surface Interferometer

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INDICATIONS

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 patients 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.

ADVERSE EFFECTS

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

ATTENTION

Reference the LipiView II Ocular Surface Interferometer Instructions for Use for a complete listing of indications, warnings, and precautions.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for LIPISCAN™ Dynamic Meibomian Imager

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Indications

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

No contraindications have been identified for the LipiScan™.

PRECAUTIONS

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.

ADVERSE EFFECTS

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

ATTENTION

Reference the LipiScan Dynamic Meibomian Imager Instructions for Use for a complete listing of indications, warnings, and precautions.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the MEIBOMIAN GLAND EVALUATOR

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)

ATTENTION

Reference the Meibomian Gland Evaluator Package Insert for a complete listing of indications, warnings, and precautions.

INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Symfony EXTENDED RANGE OF VISION IOLs

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INDICATIONS FOR USE

The TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model ZXR00 IOL is intended for capsular bag placement only.

WARNINGS

Patients with any of the conditions described in the Directions for Use may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition, or may pose an unreasonable risk to the patient’s eyesight. Lenses should not be placed in the ciliary sulcus. May cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL; fully inform the patient of this risk before implanting the lens. Special consideration should be made in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease. Inform patients to exercise special caution when driving at night or in poor visibility conditions. Some visual effects may be expected due to the lens design, including: a perception of halos, glare, or starbursts around lights under nighttime conditions. These will be bothersome or very bothersome in some people, particularly in low-illumination conditions, and on rare occasions, may be significant enough that the patient may request removal of the IOL.

PRECAUTIONS

Interpret results with caution when refracting using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is recommended. The ability to perform some eye treatments (e.g. retinal photocoagulation) may be affected by the optical design. Target emmetropia for optimum visual performance. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions.

SERIOUS ADVERSE EVENTS

The most frequently reported serious adverse events that occurred during the clinical trial of the TECNIS Symfony lens were cystoid macular edema (2 eyes, 0.7%) and surgical reintervention (treatment injections for cystoid macular edema and endophthalmitis, 2 eyes, 0.7%). No lens-related adverse events occurred during the trial.

ATTENTION:

Reference the Directions for Use for a complete listing of Indications and Important Safety Information