Download 3 Package Insert English_new 01 - Home | Johnson and Johnson

IMPORTANT: Please read carefully and
keep this informaon for future use
ACUVUE®
and
SUREVUE®
Brand Contact
Lenses
Package Insert
Polymer/water
Material
Inside-out
indicator
Extended wear
Daily wear Frequent
replacement
Lens type and Brand name
Daily Wear Daily disposable
Table 1
English
Intended Use & Wear
IMPORTANT: Please read carefully and keep this
information
for future us e ........... 3
Schedule
ACUVUE® Brand Spherical Contact Lenses - Visibility Tinted with UV Blocker
ACUVUE®2® BRAND CONTACT LENSES
etafilcon A
58/42
Y ACUVUE® Brand Contact Lenses
1-DAY ACUVUE® MOIST® BRAND CONTACT
LENSES WITH LACREON®
SUREVUE® Brand Contact Lenses
etafilcon A
58/42
etafilcon A
58/42
etafilcon A
galyfilcon A
58/42
ACUVUE® ADVANCE® Brand Contact Lenses
with HYDRACLEAR®
ACUVUE® OASYS® Brand Contact Lenses with
HYDRACLEAR® PLUS
senofilcon A
1-DAY ACUVUE® TRUEYE® BRAND CONTACT
LENSES WITH HYDRACLEAR®1
narafilcon A
ACUVUE® ADVANCE® PLUS Brand Contact
Lenses with HYDRACLEAR®
galyfilcon A
Y ACUVUE® DEFINE™ Brand Contact
Lenses with LACREON®
etafilcon A
47/53
38/62
46/54
47/53
58/42
ACUVUE® Brand Contact Lenses for ASTIGMATISM - Visibility Tinted with UV Blocker
1-DAY ACUVUE®MOIST®BRAND CONTACT
LENSES FOR ASTGMATISM WITH LACREON®
etafilcon A
1-DAY ACUVUE®BRAND CONTACT LENSES FOR
ASTGMATISM WITH LACREON
etafilcon A
58/42
ACUVUE® ADVANCE® Brand Contact Lenses
for ASTIGMATISM with HYDRACLEAR®
galyfilcon A
47/53
ACUVUE® OASYS® Brand Contact Lenses for
ASTIGMATISM with HYDRACLEAR® PLUS
senofilcon A
58/42
38/62
Key
Packaging Soluon: Buffered saline Buffered saline with methyl ether cellulose Buffered saline w
povidone. Material content: Lens material contains silicone and meets Class 1 UV absorbing standard
transmissibility of less than %1 UVB (280-315nm) and %10 UVA (316-380nm) radiation.
All etafilcon A products meet Class 2 UV absorbing standards with transmissibility of less than %5 UVB a
UVA radiation.
4
IMPORTANT: Please read
carefully and
English
keep this informaon for future use
Important: Please read carefully and keep this informaon for future use. This Package
Insert is intended for the Eye Care Professional, but should be made available to paents
upon request. This insert contains important informaon about the correct usage of
ACUVUE® and SUREVUE® Brand Contact Lenses, which are listed in Table 1 and contains
informaon about adverse reacons and contraindicaons.
Johnson & Johnson Medical Ltd provides ACUVUE® and SUREVUE® Brand Contact Lenses
Patient Instruction Guides that contain further information for contact lens wearers. The
Eye Care Professional should provide the patient with the Patient Instruction Guide that
pertains to the patient’s prescribed lens.
ACUVUE®
and
SUREVUE®
Brand Contact
Lenses
ckage Insert
3
CONTENT
Table 1
Intended Use & Wear
Packaging Soluon
Polymer/water
content (%)
ACUVUE® & SUREVUE® Spherical Brand Contact Lenses
Material
Inside-out
indicator
Extended wear
INTENDED USE
Daily wear Frequent
replacement
Lens type and Brand name
Daily Wear Daily disposable
Schedule Lenses are provided in sterile individual bl
ACUVUE® and SUREVUE® Brand Contact
packages, with the lens immersed in buffered saline solution (see Table 1 for Packa
Solution). DO NOT USE if the sterile blister package is opened or damaged.
ACUVUE® Brand Spherical Contact Lenses - Visibility Tinted with UV Blocker
Are intended for Daily Wear or Extended Wear, as shown in Table 1, for the op
58/42
etafilcon
A
ametropia (myopia and hyperopia)
in phakic
or aphakic per
Y ACUVUE®
Brand Contact Lenses
58/42
etafilcon A
with non-diseased
eyes that may have 1.00D or less of astigmatism.
ACUVUE®2®correction
BRAND CONTACT
LENSES
of refracve
1-DAY ACUVUE® MOIST® BRAND CONTACT
LENSES WITH LACREON®
1•DAY ACUVUE® DEFINE™
SUREVUE® Brand Contact Lenses
etafilcon A
58/42
ACUVUE® ADVANCE® Brand Contact Lenses
with HYDRACLEAR®
galyfilcon A
47/53
ACUVUE® OASYS® Brand Contact Lenses with
HYDRACLEAR®
PLUS
ACUVUE®
Brand Contact Lenses for Asgmasm
senofilcon A
Brand Contact Lenses with LACREON® are also intende
58/42
etafilcon A
enhance or alter the appearance of the eye.
1-DAY ACUVUE® TRUEYE® BRAND CONTACT
LENSES WITH HYDRACLEAR®1
narafilcon A
38/62
46/54
Are intended for Daily Wear or Extended Wear, as shown in Table 1, for the op
galyfilcon A
(myopia and hyperopia) in phakic 47/53
or aphakic per
ACUVUE® ADVANCE® PLUS Brand Contact
of refracve ametropia
Lenses withcorrection
HYDRACLEAR®
with non-diseased
eyes that may have astigmasm.
Y ACUVUE®
DEFINE™ Brand Contact
Lenses with LACREON®
etafilcon A
58/42
ACUVUE® Brand Contact Lenses for ASTIGMATISM - Visibility Tinted with UV Blocker
1-DAY ACUVUE®MOIST®BRAND CONTACT
LENSES FOR ASTGMATISM WITH LACREON®
etafilcon A
1-DAY ACUVUE®BRAND CONTACT LENSES FOR
ASTGMATISM WITH LACREON
etafilcon A
58/42
ACUVUE® ADVANCE® Brand Contact Lenses
for ASTIGMATISM with HYDRACLEAR®
galyfilcon A
47/53
ACUVUE® OASYS® Brand Contact Lenses for
ASTIGMATISM with HYDRACLEAR® PLUS
senofilcon A
58/42
38/62
Key
Packaging Soluon: Buffered saline Buffered saline with methyl ether cellulose Buffered saline with
povidone. Material content: Lens material contains silicone and meets Class 1 UV absorbing standards with
transmissibility of less than %1 UVB (280-315nm) and %10 UVA (316-380nm) radiation.
All etafilcon A products meet Class 2 UV absorbing standards with transmissibility of less than %5 UVB and %50
UVA radiation.
4
6
CONTENT Daily Wear - Daily Disposable
ACUVUE® Brand Contact Lenses prescribed for Daily Wear - Daily Disposable (less th
ACUVUE® and SUREVUE® Brand Contact Lenses are provided in sterile individual blister
hours, while awake) as shown in Table 1, are intended to be worn once on a
packages, with the lens immersed in buffered saline solution (see Table 1 for Packaging
disposable basis and are to be discarded upon removal. When used in this wa
Solution). DO NOT USE if the sterile blister package is opened or damaged.
cleaning or disinfection is required.
INTENDED 1USE
-DAY ACUVUE® TRUEYE® BRAND CONTACT LENSES WITH HYDRACLEAR® 1 have not
developed for use with contact lens cleaners or disinfection systems. Lenses shou
ACUVUE® &discarded
SUREVUE®after
Spherical
Brand
Contact
Lenses
use. Start
each
wearing
period with a fresh new lens.
Daily
Are intended
forWear
Daily- Frequent
Wear or Replacement
Extended Wear, as shown in Table 1, for the optical
correction of
refracve
ametropia
and hyperopia)
in phakic
aphakic persons
ACUVUE®
Brand
Contact(myopia
Lenses prescribed
for Daily
Wear or
- Frequent
Replacemen
with non-diseased
that
mayawake)
have 1.00D
or lessinof
astigmatism.
than 24eyes
hours,
while
as shown
Table
1, are to be discarded and replaced
two weeks.
1•DAY ACUVUE® DEFINE™ Brand Contact Lenses with LACREON® are also intended to
Brand Contact
Lens
for Daily Wear - Frequent Replacement (less than 24 h
enhance orSUREVUE®
alter the appearance
of the
eye.
while awake) as shown in Table 1, are to be discarded and replaced every four weeks
All ACUVUE®
SUREVUE®
Brand Contact Lenses as shown in Table 1, under the he
ACUVUE® Brand
Contactand
Lenses
for Asgmasm
of Daily Wear - Frequent Replacement are to be cleaned, rinsed and disinfected each
the
lens
is
removed
using
a
chemical
disinfection
system
only. 1, for the optical
Are intended for Daily Wear or Extended Wear,
as shown
in Table
correction of refracve ametropia (myopia and hyperopia) in phakic or aphakic persons
Extended
Wear
with non-diseased eyes that may have astigmasm.
ACUVUE® Brand Contact Lenses prescribed for Extended Wear, (greater than 24 h
including while asleep) as shown in Table 1, may be used conˆnuously for up to 7 d
nights and should be discarded upon removal. When used in this way, no clean
disinfection is required.
It is recommended that the new contact lens wearer first be evaluated on a Daily W
Frequent Replacement schedule. If in the opinion of the Eye Care Professional, the p
is determined to be an acceptable Extended Wear candidate, the Eye Care Professio
encouraged to determine a wear schedule based upon the response of the patient.
Once removed, it is recommended that the lens remains out of the eye for a period o
overnight or longer. The Eye Care Professional should examine the patient during the
stages of Extended Wear.
6
8
ACUVUE® OASYS® Brand Contact Lenses when prescribed for therapeuc use may be worn
for Daily Wear or Extended Wear.
Symbols Key
All ACUVUE®
and appear
SUREVUE®
Contact
UV Blocking
to help provide
e following
symbols may
on theBrand
label or
carton Lenses
of your have
ACUVUE®
or SUREVUE®
protection
nd Contact
Lensesagainst transmission of harmful UV radiation to the cornea and into the eye.
absorbing contact lenses
are NOT substutes
for protecve UV absorbing
MBOLWARNING: UV
DEFINITION
SYMBOL
DEFINITION
eyewear such as UV absorbing goggles or sunglasses because they do not completely
Consult Instruction Leaflet
Manufactured by or in
cover
the eye and surrounding area. You should
connue to use UV absorbing eyewear
as directed.
Use By Date (expiration date)
See table 1 for list of Brands
BatchLong-term
Code
Correct
Note:
exposure to UV radiationLens
is Orientation
one of the
risk factors associated with
cataracts. Exposure is based on a number Lens
of factors
such
as environmental conditions
Orientation
Incorrect
Sterile Using Steam or Dry Heat
(altitude, geography, cloud cover) and personal
factors (extent and nature of outdoor
(inside Out)
Contact
Lenses have
Diameter All ACUVUE® and SUREVUE® Brand
DIA activities).
Lenses
for ASTIGMATISM
only UV blocking to help
provide protection against transmission of harmful UV radiation to the cornea and in to the
Cylinder Power
BC
CYL
Curve
eye.Base
However,
clinical studies have not been done to demonstrate that wearing UV
D blocking
Dioptre contact
(lens power)
lenses reduces the AXIS
risk of Axis
developing cataracts or other eye disorders.
Consult
Eye
Care Professional
forLOW
more information.
for
Qualityyour
System
Certificaon
Symbol
“Low” near ADD (0.75+ to 1.25+ ADD)
MID
“Mid” near ADD (1.50+ to 1.75+ ADD)
Fee Paid for Waste Management
HGH
“High” near ADD (2.00+ to 2.50+ ADD)
CAUTION: US Federal law restricts this
device to sale by or on the order of a
licensed practitioner.
H-*+*J$I?.;1<;A.0A"2;@2@
D6A5"'%$J<;9F
Peel SCHEDULE
Back Foil
WEAR
The wearing and replacement schedule should be determined by the Eye Care
Professional. Patients may tend toH-*+*J$I?.;1<;A.0A"2;@2@<;9F
over wear the lenses initially. The Eye Care Professional
NATURAL
SHINE™
N
should emphasise the importance of adhering
to the
initial maximum wearing schedule.
STYLE Professional, are also extremely
Regular checkups, as determined byA the ACCENT
Eye Care
important.
VIVID STYLE
V
“Identificaon mark“ for paper
containers and wrapping
SH
NATURAL SHIMMER™
SP
NATURAL
SPARKLE™
7
V
VIVID STYLE
N
NATURAL SHINE™
A
ACCENT STYLE
1 - DAY ACUVUE® TRUEYE® BRAND CONTACT
LENSES WITH HYDRACLEAR® 1
“Identificaon mark“ for composite
materials
Do Not Re-Use (Single Use)
5
The overall
risk of ulcerative keratitis may be reduced by carefully following direc
Daily Wear •- Daily
Disposable
for lens care, including cleaning the lens case.
•
Studies
have
shown
that the risk
of ulcerative
keras
among contact
lens24users
ACUVUE® Brand Contact Lenses
prescribed
for Daily
Wear - Daily
Disposable
(less than
smoke isasgreater
among1,non-smokers.
hours, while awake)
shownthan
in Table
are intended to be worn once on a daily
disposable basis and are to be discarded upon removal. When used in this way, no
cleaning orIfdisinfection
is required.
paents experience
eye discomfort, excessive tearing, vision changes, redness of t
or other problems are experienced, they should be instructed to immediately remov
1 -DAY ACUVUE® TRUEYE® BRAND CONTACT LENSES WITH HYDRACLEAR® 1 have not been
wearer
promptly
contactsystems.
their Eye
Care
Professional
developedlenses
for useand
withthe
contact
lensshould
cleaners
or disinfection
Lenses
should
be
recommended
that wearing
contact lens
wearers
seelens.
their Eye Care Professional ro
discarded after
use. Start each
period
with a should
fresh new
as directed.
Daily Wear - Frequent Replacement
† New England Journal of Medicine, September 1989 ,21, 12) 321), pp. 773-783
ACUVUE® Brand Contact Lenses prescribed for Daily Wear - Frequent Replacement (less
than 24 hours, while awake) as shown in Table 1, are to be discarded and replaced every
two weeks.PRECAUTIONS
SUREVUE® Brand Contact Lens for Daily Wear - Frequent Replacement (less than 24 hours,
What
to do ifinproblems
occur
while awake)
as shown
Table 1, are
to be discarded and replaced every four weeks.
PLEASE
ADVISE YOUR
TO REMOVE
CONTACT
IMMEDIATELY
All ACUVUE®
and SUREVUE®
BrandPATIENT
Contact Lenses
as shown
in TableLENSES
1, under
the heading AND
ADVICE
FROMReplacement
THEIR EYE CARE
PROFESSIONAL.
of Daily Wear
- Frequent
are to
be cleaned, rinsed and disinfected each time
the lens is removed using a chemical disinfection system only.
Special Precau‹ons for Eye Care Professionals
Extended Wear
Due to the small number of patients enrolled in clinical investigaon of lens
refractive
powers,
design
configurations
or lensWear,
parameters
available
the lens m
ACUVUE® Brand
Contact
Lenses
prescribed
for Extended
(greater
than 24inhours,
are
evaluated
in significant
Consequently,
selecting
an appro
including while not
asleep)
as shown
in Table 1, numbers.
may be used
conˆnuouslywhen
for up
to 7 days/6
design
and parameters,
the Eye Care
Professional
should
all characteris
nights and lens
should
be discarded
upon removal.
When
used in this
way,consider
no cleaning
or
lens that can affect lens performance and ocular health, including o
disinfectionthe
is required.
transmissibility, wettability, central and peripheral thickness and optic zone diamete
It is recommended that the new contact lens wearer first be evaluated on a Daily Wear The potential
impact Ifofinthese
factors of
onthe
theEye
patient's
ocular health
Frequent Replacement
schedule.
the opinion
Care Professional,
theshould
patientbe ca
weighed
against
the patient's
need
forcandidate,
refractivethe
correction;
is determined
to be an
acceptable
Extended
Wear
Eye Care therefore,
Professionalthe
is con
ocular
health
of
the
patient
and
lens
performance
on
the
eye
should
be ca
encouraged to determine a wear schedule based upon the response of the patient.
monitored by the prescribing Eye Care Professional.
Once removed, it is recommended that the lens remains out of the eye for a period of rest
Due to
in light should
transmittance
cosmecally
tinted
overnight or• longer.
Thethe
Eyereducon
Care Professional
examine with
the patient
during the
earlylenses
patients
may experience visual symptoms while wearing ACUVUE® DE
stages of Extended
Wear.
Brand Contact Lenses with LACREON®. In addition, some patients may expe
peripheral awareness due to the opaque iris pa”ern.
8
10
CONTRAINDICATIONS
UE® OASYS®
Brand Contact Lenses when prescribed for therapeuc use may be worn
ily Wear or Extended Wear.
DO NOT USE ACUVUE® or SUREVUE® Brand Contact Lenses when any of the following
UVUE®
and SUREVUE®
Brand
Contactfor
Lenses
haveametropia
UV Blocking
conditions
exist, when
prescribing
refractive
use.to help provide
tion against transmission of harmful UV radiation to the cornea and into the eye.
• Acute or subacute inflammation or infec­on of the anterior chamber of the eye.
NING: •UVAny
absorbing
contact
lenses
are NOT substutes
for protecve
absorbingor eyelids.
eye disease,
injury
or abnormality
that affects
the cornea,UV
conjunctiva
ear such
UV absorbing
goggles
or sunglasses
because
they do not completely
• as
Severe
insufficiency
of lacrimal
secretion
(dry eye).
the eye
surrounding
area.(reduced
You should
connue
to use UV absorbing eyewear
• and
Corneal
hypoesthesia
corneal
sensitivity).
ected.• Any systemic disease that may affect the eye or be exaggerated by wearing contact
lenses.
Long-term
exposure
to UV
radiation
is one
of the risk
• Allergic
reactions
of ocular
surfaces
or adnexa
that factors
may be associated
induced or with
exaggerated by
cts. Exposure
is contact
based on
a number
factors lens
suchsolutions.
as environmental conditions
wearing
lenses
or use of contact
de, geography,
cloud
and personal
factors (extent
and nature
of outdoor
• Allergy to
any cover)
ingredient,
such as mercury
or Thimerosal
in a solution
which is to be
ies). All used
ACUVUE®
and
Contact
have
UV blocking
to schedule.
help
to care
forSUREVUE®
the lenses Brand
prescribed
on aLenses
frequent
replacement
wear
e protection
againstcorneal
transmission
of harmful
UVfungal,
radiation
to the cornea
• Any active
infection
(bacterial,
protozoal
or viral).and in to the
However,
studiesredhave
not been done to demonstrate that wearing UV
• If clinical
eyes become
or irritated.
ng contact lenses reduces the risk of developing cataracts or other eye disorders.
lt your
Eye
Care Professional
for more
information.
For
THERAPEUTIC
USE, the
Eye Care
Professional may prescribe ACUVUE® OASYS® Brand
Contact Lenses, to aid in the healing process of certain ocular condi‚ons, which may
SCHEDULE
include those cited above.
wearing
and replacement schedule should be determined by the Eye Care
WARNINGS
sional. Patients may tend to over wear the lenses initially. The Eye Care Professional
d emphasise
the importance
to the
initialExtended
maximumWear
wearing
schedule.
(Daily Wear
= less than of
24adhering
hours, while
awake;
= greater
than 24 hours,
ar checkups,
determined
includingas
while
asleep). by the Eye Care Professional, are also extremely
tant. Proper use and care of contact lenses and lens care products, including lens cases, are
essential for safe use. Problems from wearing contact lenses or using lens care products
could result in serious injury to the eye.
Patients should be advised of the following warnings pertaining to contact lens wear†:
• Problems with contact lenses or lens care products could result in serious injury to the
7
eye. Patients should be cau­oned
that proper use and care of contact lenses and lens
care products, including lens cases, are essential for the safe use of these products
• Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision.
• Studies have shown that the risk of ulcerative kera­­s is greater for extended wear
contact lens users than for daily wear users.
• When daily wear users wear their lenses overnight (outside the approved indication),
the risk of ulcerative kerati­s is greater than among those who do not wear them
overnight.
9
• If the
sticks (stops
moving)
on reduced
the eye,byfollow
thefollowing
recommended
directions
• The overall
risklens
of ulcerative
keratitis
may be
carefully
directions
for a Sticking
Lens".
for lens "Care
care, including
cleaning
the The
lens lens
case.should move freely on the eye for the continu
health
of
the
eye.
If
non-movement
of
the
lens
continues,
the
patient
• Studies have shown that the risk of ulcerative keras among contact lens users who should
to immediately
consult his or her Eye Care Professional.
smoke isinstructed
greater than
among non-smokers.
• Never wear lenses beyond the period recommended by the Eye Care Professional.
• If aerosol products, such as hair spray, are used while wearing lenses, exercise cauƒ
If paents experience
eyeclosed
discomfort,
excessive
tearing,
vision changes, redness of the eye
and keep eyes
until the
spray has
settled.
or other•problems
experienced,
theyvapours
should be
instructed
to immediately
remove their
Avoid allare
harmful
or irritating
and
fumes while
wearing lenses.
lenses and
theEye
wearer
promptly
contact
Eye Care
Professional.
It is dur
• The
Care should
Professional
should
warn their
the patient
about
wearing lenses
recommended
that activities,
contact lens
wearers
should see
Eye
Caresports.
Professional
routinely
sporting
especially
swimming
andtheir
other
water
Exposing
contact len
as directed.to water during swimming or while in a hot tub may increase the risk of eye infect
from microorganisms.
† New England
Journal
of recommended
Medicine, September
1989 ,21,
12) 321), pp.
773-783
• A…er
the
wearing
schedule,
always
discard lenses worn as prescribed
the Eye Care Professional.
PRECAUTIONS
Soluon Precauons
What to•doDifferent
if problems
occur cannot always be used together and not all solutions are safe
solutions
use with all lenses. Use only recommended solutions.
PLEASE •ADVISE
YOUR should
PATIENT
REMOVE
CONTACT
LENSES
IMMEDIATELY
SEEK
The patient
notTO
change
solutions
without
consulting
their Eye AND
Care Profession
ADVICE FROM THEIR EYE CARE PROFESSIONAL.
• Never use solutions recommended for rigid gas permeable (RGP) contact lenses.
• Always use fresh, unexpired lens care solutions and lenses.
Special Precau‹ons for Eye Care Professionals
• Always follow direcƒons in the package inserts for the use of contact lens solutions.
• Use only a chemical (not heat) lens care system. Use of a heat (thermal) care syst
Due to the small number of patients enrolled in clinical investigaon of lenses, all
can damage ACUVUE® and SUREVUE® Brand Contact Lenses.
refractive powers, design configurations or lens parameters available in the lens material
• Sterile unpreserved solutions, when used, should be discarded after the time specifi
are not evaluated in significant numbers. Consequently, when selecting an appropriate
in the directions.
lens design and parameters, the Eye Care Professional should consider all characteriscs of
• Do not use saliva or anything other than the recommended solutions for lubricaƒng
the lens that can affect lens performance and ocular health, including oxygen
we’ing lenses.
transmissibility, wettability, central and peripheral thickness and optic zone diameter.
• Always keep the lenses completely immersed in the recommended storage soluƒ
when the lenses are not being worn (stored). Prolonged periods of drying will red
The potential impact of these factors on the patient's ocular health should be carefully
the ability of the lens surface to return to a we’able state. Follow the lens c
weighed against the patient's need for refractive correction; therefore, the continuing
directions in "Care for a Dried Out (Dehydrated) Lens" if lens surface does beco
ocular health of the patient and lens performance on the eye should be carefully
dried out.
monitored by the prescribing Eye Care Professional.
Lens Case Precauons
• Due to the reducon in light transmittance with cosmecally tinted lenses some
patients may experience visual symptoms while wearing ACUVUE® DEFINE™
Lens cases can be a source of bacterial growth and require proper use, cleaning a
Brand Contact Lenses with LACREON®. In addition, some patients may experience
replacement at regular intervals as recommended by the lens case manufacturer or
peripheral awareness due to the opaque iris pa”ern.
Care Professional.
10
12
• Patients who wear the ACUVUE®and SUREVUE® Brand Contact Lenses to correct
NTRAINDICATIONS
presbyopia using Monovision may not achieve the best corrected visual acuity for
either
far or near
vision. Visual
requirements
vary when
with the
and should be
O NOT USE
ACUVUE®
or SUREVUE®
Brand
Contact Lenses
any individual
of the following
considered
when selecting
the most appropriate
type of lens for each patient.
nditions exist,
when prescribing
for refractive
ametropia use.
• Fluorescein, a yellow dye, should not be used while the lenses are on the eyes. The
absorb
this dye and
become of
discolored.
Whenever
Acute orlenses
subacute
inflammation
or infec­on
the anterior
chamberfluorescein
of the eye.is used in eyes,
eyes should
flushed withthat
a sterile
solutionconjunctiva
that is recommended
Any eye the
disease,
injury orbeabnormality
affectssaline
the cornea,
or eyelids. for in-eye
use.
Severe insufficiency of lacrimal secretion (dry eye).
• Eye
Care Professionals
the patient to remove the lenses immediately if
Corneal
hypoesthesia
(reduced should
cornealinstruct
sensitivity).
the eyes
become
or irritated.
Any systemic
disease
thatred
may
affect the eye or be exaggerated by wearing contact
• Eye Care Professionals should carefully instruct patients about the following care
lenses.
safety precau†ons.
Allergic regimen
reactionsand
of ocular
surfaces or adnexa that may be induced or exaggerated by
wearing contact lenses or use of contact lens solutions.
Handling
Allergy
to any Precauons
ingredient, such as mercury or Thimerosal in a solution which is to be
Before
theprescribed
Eye CareonProfessional's
office, thewear
patient
should be able to
used •to care
for leaving
the lenses
a frequent replacement
schedule.
promptly
or should
have
someone
else available who can remove the
Any active cornealremove
infectionlenses
(bacterial,
fungal,
protozoal
or viral).
lenses for
or her.
If eyes become
redhim
or irritated.
• DO NOT use if the sterile blister package is opened or damaged.
• Always USE,
washthe
and
before may
handling
lenses.ACUVUE®
Do not get
cosmetics,
r THERAPEUTIC
Eyerinse
Carehands
Professional
prescribe
OASYS®
Brand lotions,
soaps,tocreams,
deodorants
or sprays
in the eyes
orcondi‚ons,
on the lenses.
It is
best to put on
ntact Lenses,
aid in the
healing process
of certain
ocular
which
may
lenses
before
put†ng
on
makeup.
Water-based
cosmetics
are
less
likely
to damage
lude those cited above.
lenses than oil-based products.
•
Do
not
touch
contact
lenses
with
the
fingers
or
hands
if
the
hands
are
not
free of
ARNINGS
foreign materials, as microscopic scratches of the lenses may occur, causing distorted
vision
and/or
injury
to
the
eye.
aily Wear = less than 24 hours, while awake; Extended Wear = greater than 24 hours,
Carefully
follow the handling, insertion, removal, cleaning, disinfecting, storing and
luding• while
asleep).
the "Patient
Guide"
for ACUVUE®
and are
SUREVUE®
oper usewearing
and careinstructions
of contact in
lenses
and lensInstruction
care products,
including
lens cases,
Brand
Contact
Lenses from
and those
prescribed
the Eye
ential for safe use. Problems
wearing
contactby
lenses
or Care
usingProfessional.
lens care products
• Always
handle
lenses
carefully
uld result
in serious
injury
to the
eye. and avoid dropping them.
Never
tweezers
other tools
to remove
lenses
from the
lens
container unless
tients•should
beuse
advised
of theorfollowing
warnings
pertaining
to contact
lens
wear†:
specifically
indicated
that care
use. products
Pour the lens
the in
packing
into
Problems
with contact
lensesfor
or lens
couldand
result
serioussolution
injury to
thethe hand.
•
Do
not
touch
the
lens
with
fingernails.
eye. Patients should be cau­oned that proper use and care of contact lenses and lens
•
Close
supervision
is
necessary
for
the
Therapeu†c
use
of
all
ACUVUE®
OASYS®
Brand
care products, including lens cases, are essential for the safe use of these products
Contactincluding
Lenses. corneal
Ocular medications
used during
treatment
a bandage
Eye problems,
ulcers, can develop
rapidly
and leadwith
to loss
of vision.lens should
be
closely
monitored
by
the
Eye
Care
Professional.
In
certain
ocular
conditions,
only
the
Studies have shown that the risk of ulcerative kera­­s is greater for extended wear
Eye Care
will
insert
and remove the lenses. In these cases, patients should
contact lens
usersProfessional
than for daily
wear
users.
be
instructed
not
to
handle
the
lenses
themselves.
When daily wear users wear their lenses overnight (outside the approved indication),
the risk of ulcerative kerati­s is greater than among those who do not wear them
Lens Wearing Precauons
overnight.
9
11
The patient should be instructed to conduct a simple 3-part self-examination at least onc
• If the lens sticks (stops moving) on the eye, follow the recommended directions in
a day. They should ask themselves:
"Care for a Sticking Lens". The lens should move freely on the eye for the continued
• How do the lenses feel on my eyes?
health of the eye. If non-movement of the lens continues, the patient should be
• How do my eyes look?
instructed to immediately consult his or her Eye Care Professional.
• Have I noticed a change in my vision?
• Never wear lenses beyond the period recommended by the Eye Care Professional.
• If aerosol products, such as hair spray, are used while wearing lenses, exercise cauƒon
If the patient reports any problems, he or she should be instructed to IMMEDIATEL
and keep eyes closed until the spray has settled.
REMOVE THE LENS. If the discomfort or problem stops, the patient should then loo
• Avoid all harmful or irritating vapours and fumes while wearing lenses.
closely at the lens. If the lens is in any way damaged, the patient SHOULD NOT put the len
• The Eye Care Professional should warn the patient about wearing lenses during
back on the eye. The patient should discard the lens and apply a new fresh lens on the eye
sporting activities, especially swimming and other water sports. Exposing contact lenses
to water during swimming or while in a hot tub may increase the risk of eye infection
If the lens has dirt, an eyelash, or foreign body on it, or the problem stops and the len
from microorganisms.
appears undamaged, he or she should be instructed to dispose of the lens and apply a new
• A…er the recommended wearing schedule, always discard lenses worn as prescribed by
fresh lens. If the problem continues, the patient SHOULD NOT put the lens back on the ey
the Eye Care Professional.
but IMMEDIATELY CONSULT HIS OR HER EYE CARE PROFESSIONAL.
Soluon Precauons
The patient should also be instructed NOT to use a new lens as self-treatment for th
problem. The patient should be advised that when any of the above symptoms occur,
• Different solutions cannot always be used together and not all solutions are safe for
serious condition such as infection, corneal ulcer, neovascularization or iri s may b
use with all lenses. Use only recommended solutions.
present. The patient should be instructed to seek immediate professional iden fication o
• The patient should not change solutions without consulting their Eye Care Professional.
the problem and prompt treatment to avoid serious eye damage.
• Never use solutions recommended for rigid gas permeable (RGP) contact lenses.
• Always
usetherapeu c
fresh, unexpired
lens
care solutions
andbe
lenses.
During
use an
adverse
effect may
due to the original disease or injury o
• Always
in theofpackage
for the
use
of contact
lens solutions.
mayfollow
be duedirecƒons
to the effects
wearinginserts
a contact
lens.
There
is a possibility
that the existin
• Usedisease
only a chemical
(notmight
heat)become
lens care
system.
Use
of a contact
heat (thermal)
system use
or condition
worse
when
a so„
lens for care
therapeu c
canused
damage
ACUVUE®
and
SUREVUE®
Brand
Contact
Lenses.
to treat an already diseased injured eye. The patient should be instructed to avoi
• Sterile
unpreserved
solutions,
when used,
beProfessional
discarded after
the time specified
serious
eye damage
by contacting
the should
Eye Care
IMMEDIATELY
if there is a
in the
directions.
increase
in symptoms while wearing the lens.
• Do not use saliva or anything other than the recommended solutions for lubricaƒng or
we’ing
Lenslenses.
care direcons
• Always keep the lenses completely immersed in the recommended storage soluƒon
when
the lenses
lenses are
being worn
(stored).
periods
drying will
When
are not
dispensed,
the Eye
Care Prolonged
Professional
shouldofprovide
the reduce
patient wit
the appropriate
ability of the
surfacewarnings
to returnand
to instructions
a we’able state.
Follow the
andlens
adequate
in accordance
withlens
the care
individu
directions
in lens
"Care
forand
a Dried
Outschedule.
(Dehydrated)
Lens"
lens surface
does recommend
become a
patient’s
type
wearing
The Eye
CareifProfessional
should
dried
out.
appropriate
care system tailored to the patient’s individual requirements.
Lens Case
Precauons
Failure
to follow the correct lens care regime may result in serious injury to the eye, a
described in the section entitled – “Warnings”
Lens cases
can be ainformation
source of bacterial
growth
andlens
require
proper
use,cleaning,
cleaningdisinfectin
and
For complete
concerning
contact
handling,
care,
replacement
at regular
intervals
recommended
the lens
manufacturer
or Eye Bran
and storage,
refer
to the as
Patient
InstructionbyGuide
for case
ACUVUE®
or SUREVUE®
Care Professional.
Contact Lenses.
12
14
Patients who wear the ACUVUE®and SUREVUE® Brand Contact Lenses to correct
presbyopia using Monovision may not achieve the best corrected visual acuity for
Other
DiscussVisual
with Paents
either
far Topics
or neartovision.
requirements vary with the individual and should be
considered when selecting the most appropriate type of lens for each patient.
• Alwaysa contact
Care not
Professional
using
any medicine
in the
eyes.
Fluorescein,
yellow the
dye,Eye
should
be used before
while the
lenses
are on the
eyes.
The
• Certain
medications,
such discolored.
as anhistamines,
diurecs,
lenses
absorb this
dye and become
Wheneverdecongestants,
fluorescein is used
in eyes,muscle
relaxants,
tranquilizers
thosesaline
for motion
sickness
may cause dryness
of the eye,
the eyes
should be
flushed withand
a sterile
solution
that is recommended
for in-eye
use. increased lens awareness or blurred vision. Should such conditions exist, proper
remedial
measures
should
be prescribed.
Depending
onthe
thelenses
severity,
this couldifinclude
Eye Care
Professionals
should
instruct
the patient
to remove
immediately
thebecome
use of red
lubricating
drops that are indicated for use with so­ contact lenses or the
the eyes
or irritated.
temporary
discontinuance
of
contact
lens
wear
while
such
medication
is being
used.
Eye Care Professionals should carefully instruct patients about the following
care
• Oral
users could develop visual changes or changes in lens tolerance
regimen
andcontraceptive
safety precau†ons.
when using contact lenses. Patients should be cauoned accordingly.
• Precauons
As with any contact lens, follow-up visits are necessary to assure the continuing health
andling
the patient's
eyes.
TheProfessional's
patient shouldoffice,
be instructed
as to ashould
recommended
Beforeofleaving
the Eye
Care
the patient
be able follow-up
to
schedule.
promptly remove lenses or should have someone else available who can remove the
lenses for him or her.
Should
Know
That
the Paent
Contact
Lenses?
DO Who
NOT use
if the
sterile
blister
packageisisWearing
opened or
damaged.
Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions,
•
Inform
the
doctor
(Health
Care
Professional)
about
being
a contact
lensto
wearer.
soaps, creams, deodorants or sprays in the eyes or on the lenses.
It is best
put on
• Always
being a contact
lens wearer.
Some
jobstomay
require use
lenses
before inform
put†ngthe
onemployer
makeup. ofWater-based
cosmetics
are less
likely
damage
eyeoil-based
protection
equipment or may require that the patient not wear contact lenses.
lenses of
than
products.
Do not touch contact lenses with the fingers or hands if the hands are not free of
ADVERSE
REACTIONS
foreign
materials,
as microscopic scratches of the lenses may occur, causing distorted
vision and/or injury to the eye.
The
patient
should
be informed
that removal,
the following
problems
may occur
when
wearing
Carefully follow the handling,
insertion,
cleaning,
disinfecting,
storing
and
ACUVUE®
or SUREVUE®
Contact
Lenses:Guide" for ACUVUE® and SUREVUE®
wearing
instructions
in theBrand
"Patient
Instruction
Brand Contact Lenses and those prescribed by the Eye Care Professional.
• The eye may burn, sting and/or itch.
Always handle lenses carefully and avoid dropping them.
• There may be less comfort than when the lens was first placed on the eye.
Never use tweezers or other tools to remove lenses from the lens container unless
• There may be a feeling of something in the eye (foreign body, scratched area).
specifically indicated for that use. Pour the lens and the packing solution into the hand.
• There may be the potential for some temporary impairment due to peripheral
Do not touch the lens with fingernails.
infiltrates, peripheral corneal ulcers and corneal erosion. There may be the potential
Close supervision is necessary for the Therapeu†c use of all ACUVUE® OASYS® Brand
for other physiological observations, such as local or generalized oedema, corneal
Contact Lenses. Ocular medications used during treatment with a bandage lens should
neovascularization, corneal staining, injection, tarsal abnormalities, iritis and
be closely monitored by the Eye Care Professional. In certain ocular conditions, only the
conjunctivis, some of which are clinically acceptable in low amounts.
Eye Care Professional will insert and remove the lenses. In these cases, patients should
• There may be excessive watering, unusual eye secretions, or redness of the eye.
be instructed not to handle the lenses themselves.
• Poor visual acuity, blurred vision, rainbows or haloes around objects, photophobia, or
dry eyes may also occur if the lenses are worn continuously or for too long a me.
ens Wearing Precauons
11
13
REPORTING OF ADVERSE REACTIONS
The patient should be instructed to conduct a simple 3-part self-examination at least once
a day. They should
themselves:
All ask
serious
adverse experiences and adverse reactions observed in patients we
• How do the lenses
feeland
on my
eyes? Brand Contact Lenses or experienced with the lenses shou
ACUVUE®
SUREVUE®
• How do my eyes
look?
reported to:
• Have I noticed a change in my vision? Johnson & Johnson Medical Limited
Pinewood Campus
If the patient reports any problems, he or she should
be Ride
instructed to IMMEDIATELY
Nine Mile
REMOVE THE LENS. If the discomfort or problem Wokingham
stops, the patient should then look
RG3patient
40EW SHOULD NOT put the lens
closely at the lens. If the lens is in any way damaged, the
Kingdom
back on the eye. The patient should discard the lensUnited
and apply
a new fresh lens on the eye.
Tel: 4222 022 0800 Fax: 7029 783 0800
E-mail:
[email protected]
If the lens has dirt, an eyelash, or foreign body
on it,
or the problem stops and the lens
appears undamaged, he or she should be instructed to dispose of the lens and apply a new
informaon
fresh lens. If theAddional
problem continues,
the patient SHOULD NOT put the lens back on the eye
but IMMEDIATELY
OR HER EYE
CARE PROFESSIONAL.
For CONSULT
additional HIS
informaon
concerning
ACUVUE® or SUREVUE® Brand Contact Lense
to order your free copy of ACUVUE® or SUREVUE® Brand Contact Lenses P
The patient should
also be
instructed
to Customer
use a newServices
lens asonself-treatment
for the
Instruction
Guides,
pleaseNOT
contact
the address shown
above.
problem. The patient should be advised that when any of the above symptoms occur, a
serious condition
such as infection,
corneal ulcer, neovascularization or iri s may be
Manufactured
by:
present. The patient should be instructed to seek immediate professional iden fication of
refer
to cartonto
foravoid
site ofserious
manufacture
the problem andPlease
prompt
treatment
eye damage.
During therapeu c use an adverse effect may be due to the original disease or injury or
USA:
may be due to the
effects of wearing a contact lens. There IRELAND:
is a possibility that the existing
Johnson
& Johnson
Vision
Care
& Johnson
Visionwhen
Care,aInc.
disease or conditionJohnson
might become
worse
so„ contact
lens for
therapeu c
use
is (Irela
Technology
Centurion
Parkway
used to treat an already 7500
diseased
injured
eye. The patient shouldThe
beNational
instructed
to avoidPark
Limerick
Jacksonville
serious eye damage by contacting the Eye Care Professional IMMEDIATELY if there is an
Ireland
Florida,the
32256
increase in symptoms while wearing
lens.
USA
Lens care direcons
EU Authorised Representave:
Johnson & Johnson Medical Limited
When lenses are dispensed, the Eye Care Professional should provide the patient with
Pinewood Campus
appropriate and adequate warnings and instructions
accordance
with the individual
NineinMile
Ride
patient’s lens type and wearing schedule. The Eye Care
Professional should recommend an
Wokingham
appropriate care system tailored to the patient’s individual
requirements.
RG3 40EW
United Kingdom
Failure to follow the correct lens care regime may
result in serious injury to the eye, as
www.acuvue.com
described in the section entitled – “Warnings”
For complete information concerning contact lens handling, care, cleaning, disinfecting
16
and storage, refer to the Patient Instruction Guide for ACUVUE® or SUREVUE® Brand
Contact Lenses.
14
When ACUVUE® or SUREVUE® Brand Contact Lenses are recommended for frequent
replacement, as shown in Table 1, the lenses must be cleaned and disinfected following
removal
before
re-use.
The lenses may be disinfected using a chemical disinfection system
r Topics to Discuss
with
Paents
only (e.g. multi-purpose or hydrogen peroxide system).
ways contact the Eye Care Professional before using any medicine in the eyes.
Eye Care Professional
should review with
the patient lens
care directions,
rtain The
medications,
such as anhistamines,
decongestants,
diurecs,
muscle including
basic
information
onthose
lens case
cleaning
as wellmay
as specific
instructions
oneye,
the lens care
axants,
tranquilizers
and
for motion
sickness
cause dryness
of the
regimen
recommended
for
the
patient.
Since
some
lens
materials
contain
creased lens awareness or blurred vision. Should such conditions exist, propersilicone, as
shown
in
Table
1,
the
we‡ability
may
differ
when
different
lens
care
products
are used.
medial measures should be prescribed. Depending on the severity, this could include
e use of lubricating drops that are indicated for use with so­ contact lenses or the
Carediscontinuance
for a scking (non-moving)
mporary
of contact lenslens
wear while such medication is being used.
al contraceptive users could develop visual changes or changes in lens tolerance
If
the
lens
sticks
(stops
moving),
thebe
patient
should
be instructed to apply a few drops of a
hen using contact lenses. Patients
should
cauoned
accordingly.
lubricating
rewetting
solution to
directly
thecontinuing
eye and wait
until the lens
withrecommended
any contact lens,
follow-uporvisits
are necessary
assuretothe
health
begins
to
move
freely
on
the
eye
before
removing
it. If non-movement
the patient's eyes. The patient should be instructed as to a recommended
follow-upof the lens
continues
after
a
few
minutes,
the
pa‹ent
should
immediately
consult
the
Eye Care
hedule.
Professional.
Should Know That the Paent is Wearing Contact Lenses?
Care for a dried out (dehydrated) lens
orm the doctor (Health Care Professional) about being a contact lens wearer.
any ACUVUE®
or SUREVUE®
is offlens
the wearer.
eye for aSome
prolonged
period,
its surface
ways If
inform
the employer
of being aLens
contact
jobs may
require
use may
become dry
and gradually
become
non-we‡ing.
If thisnot
should
discard
the lens and
eye protection
equipment
or may
require
that the patient
wearoccur,
contact
lenses.
use a new one.
RSE REACTIONS
EMERGENCIES
patientThe
should
be informed
the following
occur
when
wearing products,
patient
should bethat
informed
that if problems
chemicalsmay
of any
kind
(household
UE® or
SUREVUE®
Brand Contact
Lenses:
gardening
solutions,
laboratory
chemicals, etc.) are splashed into the eyes, the patient
should: FLUSH EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT THE
e eyeEYE
mayCARE
burn, sting
and/or itch.OR VISIT A HOSPITAL CASUALTY DEPARTMENT WITHOUT
PROFESSIONAL
ere may
be less comfort than when the lens was first placed on the eye.
DELAY.
ere may be a feeling of something in the eye (foreign body, scratched area).
ere may be the potential for some temporary impairment due to peripheral
iltrates, peripheral corneal ulcers and corneal erosion. There may be the potential
r other physiological observations, such as local or generalized oedema, corneal
ovascularization, corneal staining, injection, tarsal abnormalities, iritis and
njunctivis, some of which are clinically acceptable in low amounts.
ere may be excessive watering, unusual eye secretions, or redness of the eye.
or visual acuity, blurred vision, rainbows or haloes around objects, photophobia, or
y eyes may also occur if the lenses are worn continuously or for too long a me.
13
15
REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing
ACUVUE® and SUREVUE® Brand Contact Lenses or experienced with the lenses should be
reported to:
Johnson & Johnson Medical Limited
Pinewood Campus
Nine Mile Ride
Wokingham
RG3 40EW
United Kingdom
Tel: 4222 022 0800 Fax: 7029 783 0800
E-mail: [email protected]
Addional informaon
For additional informaon concerning ACUVUE® or SUREVUE® Brand Contact Lenses and
to order your free copy of ACUVUE® or SUREVUE® Brand Contact Lenses Patient
Instruction Guides, please contact Customer Services on the address shown above.
Manufactured by:
Please refer to carton for site of manufacture
USA:
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville
Florida, 32256
USA
IRELAND:
Johnson & Johnson Vision Care (Ireland)
The National Technology Park
Limerick
Ireland
EU Authorised Representave:
Johnson & Johnson Medical Limited
Pinewood Campus
Nine Mile Ride
Wokingham
RG3 40EW
United Kingdom
www.acuvue.com
16