1 Indications for Use:
The TearCare® System is indicated for the application of localized heat when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, or Blepharitis.
The TearCare System is contraindicated for patients with:
• Recent (i.e. within the last 90 days) intraocular or periocular surgery.
• Recent ocular injury.
• Recent history of Ocular Herpes Simplex or Herpes Zoster.
• Active ocular or periocular infection or inflammation.
• Diminished or abnormal facial, periocular, ocular, or corneal sensation.
• Ocular surface ulcers
• Do not use the TearCare System in patients under the age of 22 years.
• Do not use the TearCare System outside the instructions for use described in this manual. Doing so can result in unanticipated patient harm.
• Do not use the TearCare System in patients with a known allergy to silicone tissue adhesives.
• Do not attempt to connect the SmartHub or SmartLid directly to an electrical outlet of any kind.
• Do not use the TearCare System in or near an MRI suite or near a magnetic field. Serious injury can occur to a patient or technician if a TearCare System is brought into an MRI suite.
• The TearCare System has not been tested in the presence of flammable anesthetics or other flammable agents in combination with air, nitrous oxide, or oxygen enriched environments.
• Use of the TearCare System in patients with eyelid abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis, etc.) may result in poor adhesion of the SmartLid to the eyelid and/or reduced benefit.
• Use caution when using the TearCare System in patients with ocular surface abnormalities (e.g. pterygium, pingueculum, corneal dystrophies, etc.) as the heat delivered by the System may aggravate these conditions.
• Remove contact lenses from the patient’s eyes prior to use of the TearCare System. Patients should wait 60 minutes after the completion of the TearCare procedure before re-inserting contact lenses.
• Do not apply the SmartLids to any other part of the patient’s body including the cornea. The SmartLids are only intended for application on the external surface of the patient’s eyelids.
• Do not reuse the SmartLids. Cross-contamination can occur if re-use is attempted.
• Do not use a TearCare System, its components, or accessories that appear damaged. Inspect all components for damage before each use.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with the use of the TearCare System include the following:
• Burn, erythema, or swelling of the eyelids
• Conjunctival infection (moderate or severe)
• Conjunctival abrasion
• Corneal abrasion
• Corneal deformation
• Allergic or inflammatory reaction to medical adhesive on the SmartLid device
• Formation of a chalazion or stye
• Decline in visual acuity
• Worsening of dry eye symptoms
• Increased discomfort or pain of ocular surface (grittiness, foreign body sensation, etc.)
• Discomfort or pain of eyelids or orbit