TearScience Dry Eye Treatment Product Safety Info

LipiView II ®

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 the LipiView II®:

Use of ophthalmic drops such as artificial tear lubricants, ointments, and medications. Advise patients not to 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 4 hours after instillation of all other ophthalmic drops prior to device use.

  • Soft or rigid contact lens wear. Advise patients to 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. Advise patients 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.

Warnings

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

Caution: The chin and forehead rest surfaces and Handheld Near IR Lid Everter must be disinfected with alcohol immediately prior to use and prior to storage.

Caution: Photo-toxicity hazard. No acute optical radiation hazards have been identified for LipiView II® under intended use conditions. Since prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged. The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. Aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible or near-infrared light source during the previous 24 hours.

Caution: The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from the instrument when operated at maximum intensity will exceed the safety guideline after 8 hours.

Caution: To prevent pinching, do not put fingers near illuminator, lens or chin rest during focusing. Instruct patient not to place hands on LipiView II® during operation, and not to put fingers near illuminator, lens or chin rest.

Caution: If a problem occurs with LipiView II®, identify the symptom then attempt to resolve the problem as indicated in Section 4, Troubleshooting Guide. If the problem cannot be resolved, stop using the device and contact TearScience.

Caution: To prevent electric shock or performance alteration, do not attempt to service the device or remove the cover. No maintenance is required for LipiView II®, and the device and all of its associated parts are not serviceable by the user.

Caution: In order to isolate this equipment from supply mains the equipment must be unplugged from the wall. Do not position the equipment in a location which would prevent the unit from being unplugged in an emergency.

Caution: Do not store this instrument in conditions where the temperature may rise above 55°C or fall below -10°C.

Caution: When lifting or handling LipiView II®, caution should be taken to prevent injury or damage to the device. Prior to moving the device, put the monitor arm into a locked position and unplug the power cord from the wall. If an external monitor is attached, disconnect the external monitor prior to moving the device.

Caution: Shock hazard. Do not touch patient and device under top cover simultaneously.

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 handheld 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. The pressure applied to the eyelid when using the device is between 0.8 g/mm2 and 1.2 g/mm2

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.

Warnings

To ensure proper use of the Meibomian Gland Evaluator™ review the warnings below.

  • Federal law restricts this device to sale by or on the order of a licensed physician.
  • Do not use Meibomian Gland Evaluator if the package is open or broken. Do not use Meibomian Gland Evaluator if it appears broken or has sharp edges or rough surfaces upon initial inspection.
  • Maintain proper infection control procedures including cleaning hands before handling the device and before evaluation of each patient. Disinfect the instrument with alcohol after each use and between patients.
  • Avoid contact of the device with the eye. Instruct the patient to look up and away to avoid injury to the cornea in the event the contact surface inadvertently touches the eye.

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 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)

LipiFlow®

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 ocularinflammation 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 (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.

Warnings

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

Caution: The patient should be under direct supervision during the entire length of treatment.

Caution: Keep Activator (Disposable) in shipping package until ready to use to protect it from damage.

Caution: Do not use Activator (Disposable) if the package is open or damaged. Do not use Activator (Disposable) if it appears broken or has rough surfaces upon inspection.

Caution: Do not attempt to re-use the Activator (Disposable).

Caution: Do not use the Activator (Disposable) after the expiration date shown on the package.

Caution: Maintain proper infection control procedures including cleaning hands before and after contact with the Activator (Disposable) for each patient and disinfecting the Console if it becomes contaminated.

Caution: Remove contact lenses from the patient’s eyes prior to treatment. The patient can resume contact lens wear one hour after completion of treatment unless there is an adverse effect, as determined by the physician and patient. In the event of an adverse effect such as, ocular surface irritation, inflammation or discomfort, advise the patient when to resume contact lens wear following resolution of the effect.

Caution: Do not use viscous lubricants with the Activator (Disposable). The Activator (Disposable) is designed to maintain a clear air space between the lid warmer and cornea to prevent corneal contact and reduce thermal transfer.

Caution: Inform the patient not to attempt to remove the Activator (Disposable) from the eye during treatment.

Caution: Inform the patient to keep eyelids closed during treatment. Verify that the patient’s eyelids are closed and in contact with the Activator (Disposable) lid warmer handle when treatment is started or restarted after pause. If the patient’s eyelids are not closed, the Activator (Disposable) will not be in the proper position to provide appropriate treatment to the eyelids.

Caution: In case of patient discomfort, the internal bladder pressure can be reduced by using the pressure controls on the touchscreen. Alternatively, the treatment can be paused at any time by pressing the Pause button on the touchscreen. Verify patient comfort while the treatment is being administered.

Caution: If a problem with the LipiFlow® System occurs, identify the symptom then attempt to resolve the problem as indicated in Chapter 16, Troubleshooting. If the problem cannot be resolved, under NO condition should treatment continue in hope that the problem will be remedied by itself. Contact TearScience® at +1 919 467 4007 in the event that a problem occurs and cannot be resolved.

Caution: To prevent electric shock or performance alteration, do not attempt to service the device or remove the cover. The device and its associated parts are not serviceable by the user.

Caution: Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the device by children or incapacitated persons may be dangerous.

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 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; and ocular surface infection.