Important Information for Contact Lens Wearers

Lenses are not a replacement for sunglasses.

Important Information for Contact Lens Wearers:

ACUVUE® Brand Contact Lenses are only available by prescription for vision correction as a daily wear lens with two-week recommended replacement. An eye care professional will determine whether contact lenses are right for you. Although rare, serious eye problems can develop while wearing contact lenses. To help avoid these problems, follow the wear and replacement schedule and lens care instructions provided by your eye doctor. Do not wear contact lenses if you have an eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. If one of these conditions occurs, remove the lens and contact your eye doctor immediately. For more information on proper wear, care and safety, talk to your eye care professional and ask for a Patient Instruction Guide, call 1-800-843-2020 or visit Acuvue.com.

Transitions, the Transitions logo and Transitions Light Intelligent Technology are trademarks of Transitions Optical, Inc. used under license by Transitions Optical Limited and Johnson & Johnson Vision Care, Inc.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for LIPIFLOW® Thermal Pulsation System

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

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).

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 TECNIS SYMFONYTM EXTENDED RANGE OF VISION IOLs

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

INDICATIONS FOR USE

The TECNIS SymfonyTM 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 SymfonyTM 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.