TrueTear® provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.
Important Safety Information
Do not use TrueTear® if you have a cardiac demand pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic device (eg, cochlear implant) in the head or neck, chronic or recurrent nosebleeds, a bleeding disorder (eg, hemophilia), a condition that can lead to increased bleeding, or a known hypersensitivity (allergy) to the hydrogel material.
Do not use TrueTear® around electronic monitoring equipment (eg, heart monitors or electrocardiogram alarms), in the bath/shower, while driving, operating machinery, or during activity in which sneezing/watery eyes may cause risk, areas other than the nose, within 3 feet of shortwave or microwave therapy equipment, around flammable anesthetic mixture (air, oxygen or nitrous oxide). Do not continue using TrueTear® if your nose is irritated. The device is limited only to the improvement in dry eye symptoms, as the safety and effectiveness for neither the treatment of dry eye disease nor use for periods longer than 6 months has been established. Safety not established in pregnancy, patients under 22 years of age, patients with nasal or sinus surgery (including nasal cautery) or significant trauma, severe nasal airway obstruction or vascularized polyp; active, severe systemic or chronic seasonal allergies; rhinitis or sinusitis requiring treatment; untreated nasal infection; and disabling arthritis, neuropathy, severe dexterity impairment or limited motor coordination. Use only manufacturer's supplied accessories.
Consult your doctor on TrueTear® instructions before use and on discontinuing use if pain, discomfort or numbness in the nose persists after reducing for higher levels/longer sessions. Remove studs, nose rings, or other nose jewelry before use. Do not use prescription eye medications or nasal sprays 30 minutes before or after using TrueTear®. Consult your doctor before use if you have suspected or diagnosed heart disease. Keep away from children. Clean as directed. Failure to replace the tip as directed will cause the device to not work properly.
Nasal pain, discomfort or burning; short-term electrical discomfort; nosebleed; nasal congestion; headaches; trace blood in nostril; facial pain; sore eye; sinus pain; pain around the eye; runny nose; nasal ulcers; and light-headedness.
Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Proper patient training on use of the device is required before home use. For the full Directions for Use, please visit www.allergan.com/truetear/usa.html or call 1-800-678-1605. Please call 1-800-433-8871 to report an adverse event.