Novartis Alcon DAILIES TOTAL1 Instructions For Use

INSTRUCTIONS FOR USE - THIS LEAFLET CONTAINS IMPORTANT PRODUCT USE AND SAFETY
INFORMATION. PLEASE READ CAREFULLY AND RETAIN FOR FUTURE REFERENCE. CONTACT
LENSES SHOULD ALWAYS BE FITTED BY AN EYE CARE PROFESSIONAL. IT IS ESSENTIAL THAT
YOU FOLLOW YOUR EYE CARE PROFESSIONAL'S DIRECTIONS AND ALL LABELING INSTRUCTIONS
FOR PROPER USE OF YOUR CONTACT LENSES.

PRODUCT IDENTIFICATION (Name):

• DAILIES TOTAL1* (delefilcon A) Water Gradient One-Day Soft Contact Lenses
• DAILIES TOTAL1* Multifocal (delefilcon A) Water Gradient One-Day Soft Contact Lenses

PRODUCT DESCRIPTION

DAILIES TOTAL1* (delefilcon A) Water Gradient Contact Lenses are made from a lens material
that is approximately 33% water and 67% delefilcon A, a silicone containing hydrogel with
added phosphatidylcholine. The color additive copper phthalocyanine is added to the lens
material to create a light blue edge-to-edge color to make it easier to see when handling.
The core lens material containing 33% water transitions through a water gradient to a
hydrogel surface layer that exceeds 80% water.

Lens Properties:

• Refractive Index hydrated: 1.42
• Light Transmittance: ≥ 93% (@ 610 nm, -1.00D)
• Oxygen Permeability (Dk): 140 x 10
(intrinsic Dk-Coulometric method)
• Water Content: 33% by weight in normal saline
• Surface Water Content: ≥ 80%

INTENDED USE

DAILIES TOTAL1* (delefilcon A) spherical soft contact lenses are indicated for the optical
correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with
non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not
interfere with visual acuity.
DAILIES TOTAL1* Multifocal (delefilcon A) soft contact lenses are indicated for the optical
correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in
phakic or aphakic persons with non-diseased eyes who may require a reading addition of
+3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of
astigmatism that does not interfere with visual acuity.
The lenses are to be used for single use, daily disposable wear (less than 24 hours while
awake) only.

CONTRAINDICATIONS (Reasons Not to Use)

Do not use (delefilcon A) contact lenses when any of the following exists:
• Allergy, inflammation, infection or irritation in or around the eye or eyelids
• Inadequate tear film (dry eye)
• Corneal hypoesthesia (reduced corneal sensitivity)
• Use of any medication that is contraindicated or interferes with contact lens wear,
including eye medications
• Any systemic disease which may be exacerbated by or interferes with contact lens wear
• If eyes become red or irritated

WARNINGS

• Daily wear lenses are not indicated for overnight wear. Delefilcon A lenses should not be
worn while sleeping.
• Serious eye problems, including corneal ulcers (ulcerative keratitis), can develop rapidly
and lead to loss of vision.
• Contact lens wear increases the risk of eye infections. Sleeping in lenses and/or smoking
further increases the risk of ulcerative keratitis for contact lens users (Schein 1989).
• If a patient experiences eye discomfort, foreign body sensation, excessive tearing, vision
changes, or redness of the eye, the patient should be instructed to immediately remove
lenses and promptly contact his or her eye care professional. It is recommended that
contact lens wearers see their eye care professional regularly as directed.
• Problems with contact lenses and lens care products could result in serious injury to the
eye. It is essential to follow their eye care professional's directions and all labeling
instructions for proper use of lenses and lens care products.

General Emergencies:

If chemicals of any kind (household products, gardening solutions, laboratory chemicals,
etc.) are splashed into the eyes:
• Flush eyes immediately with fresh saline solution or tap water.
• Remove and discard the lens and immediately contact your eye care professional or visit
a hospital emergency room without delay.

PRECAUTIONS

Special Precautions for the Eye Care Professional:
• When selecting an appropriate lens design and parameters, the eye care professional
should consider all characteristics of the lens that can affect lens performance and
-11 (cm 2 /sec) (ml O /ml x mm Hg), measured at 35°C
2
ocular health, including oxygen permeability, central and peripheral thickness and optic
zone diameter.
• The ocular health of the patient and lens performance on the eye should be carefully
evaluated on initial dispensing and monitored on an ongoing basis by the prescribing
eye care professional.
• Fluorescein, a yellow dye, should not be used while the lenses are on the patient's eyes.
The lenses absorb this dye and become discolored.
• Patients who wear contact lenses to correct presbyopia may not achieve the best
corrected visual acuity for either far or near vision. Vision requirements vary with the
individual and should be considered when selecting the most appropriate type of lens
for each patient.
• Diabetics may have reduced corneal sensitivity and thus are more prone to corneal
injury and do not heal as quickly or completely as non-diabetics.
• Visual changes or changes in lens tolerance may occur during pregnancy or use of oral
contraceptives. Caution patients accordingly.
• Eye care professionals should instruct the patient to remove the lenses immediately if
the eye becomes red or irritated.
• Before leaving the eye care professional's office, patients should be able to promptly
remove their lenses or should have someone else available who can remove their lenses
for them.
• Routine eye examinations are necessary to help assure the continued health of the
patient's eyes. Alcon recommends that patients see their eye care professional once each
year, or more often, as recommended by the eye care professional.

Lens Wearing Precautions:

• Check eyes daily to ensure they look well, feel comfortable and your vision is clear.
• Do not use if blister pack is damaged or not completely sealed. This may result in
product contamination which can lead to a serious eye infection.
• The lenses are not intended to be cleaned or disinfected and should be discarded after a
single use. Reuse can increase the risk of infection or fatigue-induced device failure.
• Do not share lenses with anyone as this may spread micro-organisms which could result
in serious eye health problems.
• Never allow contact lenses to come into contact with non-sterile liquids (including tap
water and saliva) as microbial contamination can occur, which may lead to permanent
eye damage.
• Consult your eye care professional before wearing lenses during sporting activities
including swimming and water related activities. Exposure to water (or other
non-sterile liquids) while wearing contact lenses in activities such as swimming, water
skiing, and hot tubs may increase the risk of ocular infection, including but not limited
to Acanthamoeba keratitis.
• Remove and discard lenses when exposed to noxious or irritating vapor.
• Discard a contact lens that has become dehydrated or damaged. Replace with a fresh
new lens.
• It is recommended that contact lens wearers visit their eye care professional regularly as
directed.
• Inform employer that you wear contact lenses, especially if job involves using eye
protection equipment.
• Keep a note of the correct lens power for each eye. Before lens insertion, check that the
lens power on each foil pack is correct for that eye.
• Be careful while using soaps, lotions, creams, cosmetics or deodorants as they can cause
irritation if they come into contact with your lenses.
• Insert lenses before applying make-up and remove them before taking make-up off.
• Always carry spare lenses with you or have back-up spectacles available.
• Do not use lenses after the expiry date.

ADVERSE REACTIONS (Possible problems and what to do)

Problems may occur with contact lens wear and may first present as one or more of the
following signs and symptoms:
• Foreign body sensation (feeling of something in the eye)
• Uncomfortable lens
• Eye redness
• Sensitivity to light (photophobia)
• Burning, stinging, itching or watering eyes
• Reduced sharpness of vision
• Rainbows or halos around lights
• Increased eye secretions
• Discomfort or pain
• Severe or persistent dry eyes
These symptoms, if ignored, may lead to more serious complications.

WHAT TO DO IF A PROBLEM OCCURS

• If any of the above signs or symptoms occur:
o Immediately remove the lens(es).
o Inspect the affected eye(s) in a mirror looking for signs of irregularity.
• If the sign or symptom stops, insert a fresh, new lens.
• If the sign or symptom persists or if it returns after insertion of a new
lens(es), remove the lens(es) and immediately contact your eye care
professional.
o A serious condition such as infection, corneal ulcer (ulcerative keratitis), or iritis
may be present.