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Important Safety Information

Important Safety Information for ACUVUE® VITA Brand Contact Lenses

ACUVUE® VITA Brand Contact Lenses are indicated for vision correction as a daily wear lens with one-month recommended replacement. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from Johnson & Johnson Vision Care division of Johnson & Johnson Inc., by calling 1-800-267-5098 or by visiting jnjvisionpro.ca.

Important safety information for all brands (except 1-DAY ACUVUE® DEFINE® and ACUVUE® Theravision® with Ketotifen)

ACUVUE® Brand Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from Johnson & Johnson Vision Care division of Johnson & Johnson Inc., by calling 1-800-267-5098 or by visiting jnjvisionpro.ca.

Important Safety Information for 1-DAY ACUVUE® DEFINE® Brand Contact Lenses

1-DAY ACUVUE® DEFINE® Brand Contact Lenses are available with and without vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information, available from Johnson & Johnson Vision Care division of Johnson & Johnson Inc., by calling 1-800-267-5098 or by visiting jnjvisionpro.ca.

UV Disclaimer

Helps protect against transmission of harmful UV radiation to the cornea and into the eye.

WARNING: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses, because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed. NOTE: Long-term exposure to UV radiation is one of the risk factors associated with cataracts. Exposure is based on a number of factors such as environmental conditions (altitude, geography, cloud cover) and personal factors (extent and nature of outdoor activities). UV-blocking contact lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-blocking contact lenses reduces the risk of developing cataracts or other eye disorders.

For additional information about indications, contraindications, warnings and precautions for a particular product, please select the link below to download the product package insert.

Important Safety Information for ACUVUE® Theravision® with Ketotifen Contact Lenses

ACUVUE® Theravision® with Ketotifen contact lenses are available by prescription only for patients who require vision correction and experience ocular allergic itch due to allergic conjunctivitis. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness, narrow angle glaucoma or other eye problems. Consult the package insert for complete information. Complete information is also available from Johnson & Johnson Vision Care division of Johnson & Johnson Inc., or by calling 1-800-267-5098, or by visiting jnjvisionpro.ca.

1-DAY wear

1-DAY ACUVUE® DEFINE® Brand
1-DAY ACUVUE® TruEye® Brand (narafilcon A)
1-DAY ACUVUE® MOIST Brand
1-DAY ACUVUE® MOIST Brand for ASTIGMATISM
1-DAY ACUVUE® MOIST Brand MULTIFOCAL
ACUVUE OASYS® Brand 1-Day with HydraLuxe
ACUVUE OASYS® Brand 1-Day for ASTIGMATISM

Two-week wear

ACUVUE OASYS® Brand
ACUVUE OASYS® Brand for ASTIGMATISM
ACUVUE OASYS® Brand for PRESBYOPIA
ACUVUE® 2 Brand

Monthly wear

ACUVUE® VITA Brand
ACUVUE® VITA Brand for ASTIGMATISM

ACUVUE® RevitaLens Multi-Purpose Disinfecting Solution is indicated for the care of soft (hydrophilic) contact lenses, including silicone hydrogel lenses. Use this product, as recommended by your eye care professional, to disinfect, clean, rinse, store, remove protein and condition your contact lenses. If you are allergic to any ingredient in ACUVUE® RevitaLens MPDS do not use this product. Problems with contact lenses and contact lens care products could result in corneal infection and/or ulcers and lead to loss of vision. It is essential that you follow your eye care professional’s directions and all labeling instructions for proper use of lenses and lens care products, including the contact lens case.

Use Blink Contacts® and Blink-N-Clean® Drops to lubricate and rewet soft and gas permeable contact lenses to help relieve dryness and irritation that may be associated with contact lens wear and to cushion lenses by placing a drop on the eye prior to the application on the eye. If you are allergic to any ingredients in Blink Contacts® or Blink-N-Clean® Drops, do not use these products. Patients should stop use and contact their eye care professional if they experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Blink® Moisturizing Drops and Blink® Intensive Drops are for the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun, and may be used as a protectant against further irritation. Patients should stop use and contact their eye care professional if they experience pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

PP2021MLT5684

 

SUMMARY OF INDICATIONS AND IMPORTANT SAFETY INFORMATION

FOR THE LIPIFLOW® THERMAL PULSATION SYSTEM

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 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 (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)
  • Esthetic eyelid and eyelash procedures (e.g., blepharoplasty, lash extensions, eyelid tattooing)

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 (e.g., edema, bruising, blood blister, dermatitis, hordeolum or chalazion)
  • Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival edema or conjunctival injection (hyperemia)
  • 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
  • Ocular surface (corneal) infection

ATTENTION

Reference the LipiFlow® System Instructions for Use for a complete listing of indications, warnings, and precautions.

 

FOR THE LIPISCAN® DYNAMIC MEIBOMIAN IMAGER

INDICATIONS FOR USE

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.

 

FOR THE LIPIVIEW® II OCULAR SURFACE INTERFEROMETER

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.

All of these image types can be photographically documented and visually monitored.

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 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 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 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 Instructions for Use for a complete listing of indications, warnings, and precautions.

 

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.

WARNINGS

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

  • 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 devices 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.

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.

PP2019TS4210