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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 connuously 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 Certificaon 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 Precauons 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 connuouslywhen 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 paern. 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 condions, 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 cau 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 Precauons for Eye Care Professionals • Always follow direcons 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 lubricang the lens that can affect lens performance and ocular health, including oxygen weing lenses. transmissibility, wettability, central and peripheral thickness and optic zone diameter. • Always keep the lenses completely immersed in the recommended storage solu 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 weable 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 paern. 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 precauons. 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 orcondions, on the lenses. It is best to put on ntact Lenses, aid in the healing process of certain ocular which may lenses before putng 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 Therapeuc 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 cauon 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 duedirecons 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 lubricang or weing Lenslenses. care direcons • Always keep the lenses completely immersed in the recommended storage soluon 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 weable 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 precauons. 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 putngthe 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 Therapeuc 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 weability 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 paent 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-weing. 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