BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses For Planned Replacement

Transcription

1 BIOFINITY (cmfilcn A) Sft (Hydrphilic) Cntact Lenses Fr Planned Replacement IMPORTANT: Please read carefully and keep this infrmatin fr future use. This package insert is intended fr the Eye Care Practitiner, but shuld be made available t patients upn request. The Eye Care Practitiner shuld prvide the patient with the patient instructins that pertain t the patient's prescribed lens. SYMBOLS KEY The fllwing symbls may appear n the label r cartn. SYMBOL DEFINITION Cautin: Federal (USA) law restricts this device t sale by r n the rder f a licensed practitiner See Instructins fr Wearers Use by Date (expiratin date) Batch Cde Sterile using Steam Heat CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PRACTITIONER. DESCRIPTION BIOFINITY (cmfilcn A) Cntact Lenses are available as spheric, aspheric, tric and multifcal lens designs. The lenses are made frm a material cntaining 48% water and 52% cmfilcn A, a silicne-cntaining hydrgel. The lenses have a tint (phthalcyanine blue) which is added t make the lens mre visible fr handling. BIOFINITY and BIOFINITY XR SPHERE and ASPHERE cntact lenses parameters: Diameter: 13.5 mm t 15.0 mm Base Curve: 8.0 mm t 9.5 mm Center Thickness: mm t 0.60 mm (varies with pwer) Pwers: D t D BIOFINITY TORIC and BIOFINITY XR TORIC cntact lenses parameters: Diameter: 13.5 mm t 15.0 mm Base Curve: 8.0 mm t 9.5 mm Center Thickness: 0.08 mm t 0.60 mm (varies with pwer) Pwers: D t D Cylinder: D t D Axis: 0 t 180 BIOFINITY MULTIFOCAL and BIOFINITY XR MULTIFOCAL cntact lenses parameters: Diameter: 13.5 mm t 15.0 mm Base Curve: 8.0 mm t 9.5 mm Center Thickness: 0.08 mm t 0.60 mm (varies with pwer) Pwers: D t D Additin Pwers: D t D The physical/ptical prperties f the lens are: Refractive Index: 1.40 Light Transmittance: >97% Surface Character Hydrphilic Water Cntent 48% Specific Gravity 1.04 Oxygen Permeability: 128 x (cm2/sec)(ml 02/ml x mmhg) 35 C (Culmetric methd) ACTIONS When placed n the crnea in its hydrated state, the BIOFINITY (cmfilcn A) Sft (Hydrphilic) Cntact Lens acts as a refracting medium t fcus light rays n the retina. The tric lens prvides a mre even surface ver the uneven astigmatic crnea and thus helps t fcus light rays n the retina. INDICATIONS FOR USE Spherical and Aspherical BIOFINITY and BIOFINITY XR (cmfilcn A) SPHERE and ASPHERE Sft Cntact lenses are indicated fr the crrectin f ametrpia (mypia and hyperpia) in aphakic and nn-aphakic persns with nndiseased eyes in pwers frm t dipters. The lenses may be wrn by persns wh exhibit astigmatism f 2.00 dipters r less that des nt interfere with visual acuity. Tric BIOFINITY (cmfilcn A) TORIC and BIOFINITY XR TORIC (cmfilcn A) Sft Cntact lenses are indicated fr the crrectin f ametrpia (mypia r hyperpia with astigmatism) in aphakic and nnaphakic persns with nn-diseased eyes in pwers frm t dipters and astigmatic crrectins frm t dipters Multifcal BIOFINITY (cmfilcn A) MULTIFOCAL and BIOFINITY XR MULTIFOCAL (cmfilcn A) lenses are indicated fr the crrectin f refractive ametrpia (mypia and hyperpia) and emmetrpia with presbypia in aphakic and nn-aphakic persns with nn-diseased eyes in pwers frm t dipters and with add pwers frm t dipters. The lenses may be wrn by persns wh exhibit astigmatism f 2.00 dipters r less that des nt interfere with visual acuity. The BIOFINITY (cmfilcn A) Sft (Hydrphilic) Cntact Lenses have been apprved fr extended wear fr up t 6 nights /7 days f cntinuus wear. It is recmmended that the cntact lens wearer first be evaluated n a daily wear schedule. If successful, then a gradual intrductin f extended wear can be fllwed as determined by the prescribing Eye Care Practitiner. Eye Care Practitiners may prescribe the lens fr frequent replacement wear, with cleaning, disinfecting and scheduled replacements (see WEARING SCHEDULE) CONTRAINDICATIONS (REASONS NOT TO USE) D nt use the BIOFINITY lens when any f the fllwing cnditins exist: Acute and subacute inflammatin r infectin f the anterir chamber f the eye. Any eye disease, injury, r abnrmality that affects the crnea, cnjunctiva, r eyelids. Severe insufficiency f lacrimal secretin (dry eyes). Crneal hypesthesia (reduced crneal sensitivity), if nt aphakic. Any systemic disease that may affect the eye r be exaggerated by wearing cntact lenses. Allergic reactins f cular surfaces r adnexa that may be induced r exaggerated by wearing cntact lenses r use f cntact lens slutins. Allergy t any ingredient, such as mercury r thimersal, in a slutin, which is t be used t care fr any BIOFINITY lens. Any active crneal infectin (bacterial, fungal, r viral). If eyes becme red r irritated. The patient is unable t fllw lens care regimen r unable t btain assistance t d s. Call ur Custmer Service Department at (800) fr current availability.

2 WARNINGS: PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential that the patient fllws the directins f the eye care practitiner and all labeling instructins fr prper use f cntact lenses and lens care prducts, including the lens case. Patients shuld be advised f the fllwing instructins fr use and warnings pertaining t cntact lens wear: i. Saking and String the Lenses ii. iii. Instructin fr Use: Use nly fresh multi-purpse (cntact lens disinfecting) slutin each time the patient saks (stres) the lenses. D nt reuse r tp ff ld slutin left in the lens case since slutin reuse reduces effective lens disinfectin and culd lead t severe infectin, visin lss r blindness. Tpping-Off is the additin f fresh slutin t slutin that has been sitting in the case. Rub and Rinse Time Instructin fr Use: Rub and rinse the lenses accrding t the recmmended lens rubbing and rinsing times in the labeling f the multipurpse slutin t adequately disinfect the lenses. Rub and rinse the lenses fr the recmmended amunt f time t help prevent serius eye infectins. Never use water, saline slutin, r rewetting drps t disinfect the lenses. These slutins will nt disinfect the lenses. Nt using the recmmended disinfectant can lead t severe infectin, visin lss r blindness. Lens Case Care Instructin fr Use: Empty and clean cntact lens cases with digital rubbing using fresh, sterile disinfecting slutins/cntact cleaner. Never use water. Cleaning shuld be fllwed by rinsing with fresh, sterile disinfecting slutins (never use water) and wiping the lens cases with fresh, clean tissue is recmmended. Never air-dry r recap the lens case lids after use withut any additinal cleaning methds. If air drying, be sure that n residual slutin remains in the case befre allwing it t dry. Replace the lens case accrding t the directins given by the eye care prfessinal r the labeling that came with the case. Cntact lens cases can be a surce f bacterial grwth. Water can harbr micrrganisms that can lead t severe infectin, visin lss r blindness. If the lenses have been submersed in water when swimming in pls, lakes r ceans, discard them and replace them with a new pair. Ask the eye care practitiner (prfessinal) fr recmmendatins abut wearing the lenses during any activity invlving water. v. Discard Date n Multi-purpse Slutin Bttle Instructin fr Use: Discard any remaining slutin after the recmmended time perid indicated n the bttle f multi-purpse slutin used fr disinfecting and saking the cntact lenses. The Discard date refers t the time t safely use cntact lens care prduct after the bttle has been pened. It is nt the same as the expiratin date, which is the last date that the prduct is still effective befre it is pened. Using the multi-purpse slutin beynd the discard date culd result in cntaminatin f the slutin and can lead t severe infectin, visin lss r blindness. T avid cntaminatin, DO NOT tuch tip f cntainer t any surface. Replace cap after using. T avid cntaminating the slutin, DO NOT transfer t ther bttles r cntainers. EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF VISION; IF THE FOLLOWING IS EXPERIENCED: Eye Discmfrt, Excessive Tearing, Visin Changes; Lss f Visin, Eye Redness Or Other Eye Prblems PATIENTS SHOULD BE INSTRUCTED TO IMMEDIATELY REMOVE THE LENSES, AND PROMPTLY CONTACT THE EYE CARE PRACTITIONER. Daily wear lenses are nt indicated fr vernight wear, and patients shuld be instructed nt t wear lenses while sleeping. Clinical studies have shwn that risk f serius adverse reactins is increased when these lenses are wrn vernight. Studies have shwn that cntact lens wearers wh are smkers have a higher incidence f adverse reactins than nnsmkers. D nt stre the lenses r rinse the lens case with water r any nn-sterile slutin. Only use fresh multi-purpse slutin t nt cntaminate the lenses r lens case. Use f nn-sterile slutin can lead t severe infectin, visin lss r blindness. iv. Water Activity Instructin fr Use: D nt expse the cntact lenses t water while wearing them.

3 Patients shuld be cautined that prper use and care f the cntact lenses and lens care prducts, including lens cases, are essential fr the safe use f these prducts. It is essential that patients fllw their Eye Care Practitiner s directins and all labeling instructins fr prper use f lenses and lens care prducts. Patients shuld fill their lens case with fresh slutin every time they stre their lenses, and never re-use slutin. Additinally, they shuld clean and rinse their lens case between uses as recmmended by their Eye Care Practitiner. Eye prblems, including crneal ulcers, can develp rapidly and lead t lss f visin. The result f a study 1 indicate the fllwing: a. The verall annual incidence f ulcerative keratitis in daily wear cntact lens users is estimated t be abut 4.1 per 10,000 persns and abut 20.9 per 10,000 persns in extended wear cntact lens users. b. The risk f ulcerative keratitis is 4 t 5 times greater fr extended wear cntact lens users than fr daily wear users. When daily wear users wh wear their lenses vernight and extended wear users wh wear their lenses n a daily basis are excluded frm the cmparisn, the risk amng extended wear users are 10 t 15 times greater than amng daily wear users. c. When daily users wear their lenses vernight (utside the apprved indicatin), the risk f ulcerative keratitis is 9 times greater than amng thse wh d nt wear them vernight. d. The verall risk f ulcerative keratitis may be reduced by carefully fllwing directins fr lens care, including cleaning the lens case. e. The risk f ulcerative keratitis amng cntact lens users wh smke is estimated t be 3 t 8 times greater than amng nn-smkers. f. If patients experience eye discmfrt, excessive tearing, visin changes, redness f the eye r ther prblems, they shuld be instructed t immediately remve their lenses and prmptly cntact their Eye Care Practitiner. It is recmmended that cntact lens wears see their Eye Care Practitiner rutinely as directed. 1 NewEnglandJurnalfMedicine,September21,1989;321(12),pp PRECAUTIONS Special Precautins fr Eye Care Practitiners Due t the small numbers f patients enrlled in clinical investigatin f lenses, all refractive pwers, design cnfiguratins, r lens parameters available in the lens material are nt evaluated in significant numbers. Cnsequently, when selecting an apprpriate lens design and parameters, the Eye Care Practitiner shuld cnsider all characteristics f the lens that can affect lens perfrmance and cular health, including xygen permeability, wettability, central and peripheral thickness, and ptic zne diameter. The ptential impact f these factrs n the patient s cular health shuld be carefully weighed against the patient s need fr refractive crrectin; therefre, the cntinuing cular health f the patient and lens perfrmance n the eye shuld be carefully mnitred by the prescribing Eye Care Practitiner. Patients wh wear cntact lenses t crrect presbypia may nt achieve the best crrected visual acuity fr either far r near visin. Visual requirements vary with the individual and shuld be cnsidered when selecting the mst apprpriate type f lens fr each patient. Aphakic patients shuld nt be fitted with any BIOFINITY cntact lenses until the determinatin is made that the eye has healed cmpletely. Flurescein, a yellw dye, shuld nt be used while the lenses are n the eyes. The lenses absrb the dye and becme disclred. Whenever flurescein is used in the eyes, the eyes shuld be flushed with a sterile saline slutin that is recmmended fr in-eye use. Befre leaving the Eye Care Practitiner s ffice, the patient shuld be able t prmptly remve the lenses r shuld have smene else available wh can remve the lenses fr him r her. Eye Care Practitiners shuld instruct the patient t remve the lenses immediately if the eye becmes red r irritated. Eye Care Practitiners shuld carefully instruct patients abut the fllwing care regimen and safety precautins: D nt use saliva r anything ther than the recmmended slutins fr lubricating r wetting lenses. Never use slutins recmmended fr cnventinal hard cntact lenses nly. Always fllw the directins in the package inserts fr the use f cntact lens slutins. Always use a chemical lens care system. Use f heat care system can damage the cmfilcn A cntact lenses. Sterile unpreserved slutins, when used, shuld be discarded after the time specified in the labeling directins. If the lens sticks (stps mving) n the eye, fllw the recmmended directins n Care fr a Sticking Lens. The lens shuld mve freely n the eye fr the cntinued health f the eye. If nn-mvement f the lens cntinues, the patient shuld be instructed t immediately cnsult his r her Eye Care Practitiner. Always wash and rinse hands befre handling lenses. D nt get csmetics, ltins, saps, creams, dedrant, r sprays in the eyes r n the lenses. It is best t put n lenses befre putting n makeup. Water-based csmetics are less likely t damage lenses than il-based prducts. D nt tuch the cntact lenses with the finger r hands if the hands are nt free f freign materials, as lens damage may ccur. Always handle lenses gently and avid drpping them. Never use tweezers r ther tls t remve lenses frm the lens cntainer unless specifically indicated fr that use. Pur the lens int yur hand. D nt tuch the lens with fingernails. Carefully fllw the handling, insertin, remval, cleaning, and wearing instructins in the Patient Instructins fr BIOFINITY cntact lenses and thse prescribed by the Eye Care practitiner. Never wear lenses beynd the perid recmmended by the Eye Care Practitiner. Always discard dispsable lenses and lenses wrn n a frequent replacement schedule after the recmmended wearing schedule prescribed by the Eye Care Practitiner. Avid all harmful r irritating vaprs and fumes while wearing lenses. If aersl prducts such as hairspray are used while wearing lenses, exercise cautin and keep eyes clsed until the spray has settled. Ask the Eye Care Practitiner abut wearing the lenses during sprting activities. Infrm the dctr (Health Care Practitiner) abut being a cntact lens wearer. Always cntact the Eye Care Practitiner befre using any medicine in the eyes. Always infrm the emplyer f being a cntact lens wearer. Sme jbs may require use f eye prtectin equipment r may require that the patient nt wear cntact lenses. As with any cntact lens, fllw-up visits are necessary t assure the cntinuing health f the patient s eyes. The patient shuld be instructed as t a recmmended fllw-up schedule. ADVERSE REACTIONS The patient shuld be infrmed that the fllwing prblems may ccur: Eyes stinging, burning, r itching (irritatin), r ther eye pain. Cmfrt is less than when the lens was first placed n the eye. Feeling that smething is in the eye such as a freign bdy r a scratched area. Excessive watering (tearing) f the eyes. Unusual eye secretins. Redness f the eyes. Reduced sharpness f visin (pr visual acuity). Blurred visin, rainbws, r hals arund bjects. Sensitivity t light (phtphbia). Dry eyes.

4 If the patient ntices any f the abve, he r she shuld be instructed t: Immediately remve the lenses. If the discmfrt r the prblem stps, then lk clsely at the lens. If the lens is in sme way damaged, d nt put the lens back n the eye. Place the lens in the strage case and cntact the eye care practitiner. If the lens has dirt, an eyelash, r ther freign bdy n it, r the prblem stps and the lens appears undamaged, the patient shuld thrughly clean, rinse, and disinfect bth lenses; then reinsert them. After reinsertin, if the prblem cntinues the patient shuld immediately remve the lenses and cnsult the Eye Care Practitiner. When any f the abve prblems ccur, a serius cnditin such as infectin, crneal ulcer, nevascularizatin, r iritis may be present. The patient shuld be instructed t keep the lens ff the eye and seek immediate prfessinal identificatin f the prblem and prmpt treatment t avid serius eye damage. FITTING Cnventinal methds f fitting cntact lenses apply t all BIOFINITY cntact lenses. Fr a detailed descriptin f the fitting techniques, refer t the BIOFINITY Prfessinal Fitting and Infrmatin Guide, cpies f which are available frm: WEARING SCHEDULE CperVisin, Inc. 711 Nrth Rad Scttsville, New Yrk The wearing and replacement schedules shuld be determined by the Eye Care Practitiner. Patients tend t ver-wear the lenses initially. The Eye Care Practitiner shuld emphasize the imprtance f adhering t the initial maximum wearing schedule. Regular checkups, as determined by the eye care practitiner are als extremely imprtant. CperVisin recmmends that all BIOFINITY lenses be discarded and replaced with a new lens n a frequent replacement basis. The eye care practitiner is encuraged t determine an apprpriate lens replacement schedule based upn the respnse f the patient. DAILY WEAR: (less than 24 hurs, while awake). The maximum suggested wearing time is: DAY Hurs Day Hurs All waking hurs The Eye Care Practitiner shuld determine the wearing and replacement schedule, based upn the patient s histry and their cular examinatin, as well as the practitiner s experience and clinical judgment. EXTENDED WEAR: BIOFINITY cntact lenses may be prescribed fr daily wear and extended wear fr up t 6 nights/ 7 days f cntinuus day and night wear. Nt all patients can achieve the maximum wear time. It is recmmended that the cntact lens wearer be evaluated n a daily wear schedule. If successful, then a gradual intrductin f extended wear can be fllwed as determined by the prescribing Eye Care Practitiner. Once remved, it is recmmended that the lens remain ut f the eye fr a perid f rest vernight r lnger and discarded in accrdance with the prescribed wearing schedule. The Eye Care Practitiner shuld determine the apprpriate wearing time and prvide specific instructins t the patient regarding lens care, insertin and remval. LENS CARE DIRECTIONS Eye Care Practitiners shuld review with the patient lens care directins, including bth basic lens care infrmatin and specific instructins n the lens care regimen recmmended fr the patient. Always wash, rinse, and dry hands befre handling cntact lenses. D nt use saliva r anything ther than the recmmended slutins fr lubricating r rewetting. D nt put lenses in the muth. The patient shuld always have a spare pair f lenses at all times. General Lens Care: (Fr Planned Replacement) Basic Instructins: Always use fresh, unexpired lens care slutins. Use the recmmended chemical (nt heat) system f lens care and carefully fllw instructins n slutin labeling. Different slutins cannt always be used tgether, and nt all slutins are safe t use with all lenses. D nt alternate r mix lens care systems unless indicated n slutin labeling. Lenses shuld be cleaned, rinsed, and disinfected each time they are remved. Cleaning and rinsing are necessary t remve mucus and film frm the lens surface. Disinfecting is necessary t destry harmful germs. Always remve, clean, rinse, (as recmmended by the eye care practitiner) and disinfect lenses accrding t the schedule prescribed by the eye care practitiner. The use f an enzyme cleaner is nt recmmended. The eye care practitiner shuld recmmend a care system that is apprpriate fr BIOFINITY cntact lenses. Each lens care prduct cntains specific directins fr use and imprtant safety infrmatin, which shuld be read and carefully fllwed. Nte: Sme slutins may have mre than ne functin, which will be indicated n the label. Read the label n the slutin bttle, and fllw directins. Clean ne lens first (always the same lens first t avid mix-ups), rinse the lens thrughly with recmmended saline r disinfectin slutin t remve cleaning slutin, mucus, and film frm the lens surface, and put that lens int the crrect chamber f the lens strage case. Then repeat the prcedure fr the secnd lens. After cleaning, and rinsing, disinfect lenses using the system recmmended by the manufacturer and/r Eye Care Practitiner. T stre lenses, disinfect and leave them in the clsed/unpened case until ready t wear. If lenses are nt t be used immediately fllwing disinfectin, the patient shuld be instructed t cnsult the package insert r the eye care practitiner fr infrmatin n the strage f lenses. After remving the lenses frm the lens case, empty and rinse the lens strage case with slutin as recmmended by the lens case manufacturer; then allw the lens case t air dry. When the lens case is used again, refill it with strage slutin. Replace the lens case at regular intervals as recmmended by the lens case manufacturer r yur Eye Care Practitiner. Eye Care Practitiners may recmmend a lubricatin/rewetting slutin, which can be used t wet (lubricate) the lenses while they are being wrn t make them mre cmfrtable. CHEMICAL LENS DISINFECTION (Including Hydrgen Perxide): Clean the cntact lenses with a recmmended cleaning slutin and thrughly rinse them with a recmmended rinsing slutin. After cleaning and rinsing, t disinfect, carefully fllw the instructins accmpanying the disinfecting slutin in the eye care regimen recmmended by the lens manufacturer r the Eye Care Practitiner. When using hydrgen perxide lens care systems, lenses must be neutralized befre wearing. Fllw the recmmendatins n the hydrgen perxide system labeling. When using hydrgen perxide lens care systems, the patient must use ONLY the lens case prvided with the hydrgen perxide care system. This case is specially designed t neutralize the slutin. Failure t use the specialized case will result in severe stinging, burning, and injury t the eye. Fllw the recmmendatins n the hydrgen perxide system labeling exclusively. Fllwing disinfectin with a perxide system, the lenses shuld be rinsed with sterile saline.

5 Thrughly rinse lenses with a fresh slutin recmmended fr rinsing befre inserting and wearing, r fllw the instructins n the disinfectin slutin labeling. D nt heat the disinfectin slutin and lenses. Leave the lenses in the unpened strage case until ready t put n the eyes. CAUTION: Lenses that are chemically disinfected may absrb ingredients frm the disinfecting slutin which may be irritating t the eyes. A thrugh rinse in fresh sterile saline slutin prir t placement in the eye shuld reduce the ptential fr irritatin. LENS CASE CLEANING AND MAINTENANCE Cntact lens cases can be a surce f bacteria grwth. Lens cases shuld be emptied, cleaned, and rinsed with slutin recmmended by the lens case manufacturer, and allwed t air dry. Lens cases shuld be replaced at regular intervals as recmmended by the lens case manufacturer r the Eye Care Practitiner. THE EYE CARE PRACTITIONER OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. HOW SUPPLIED Each lens is supplied sterile in a blister pack cntaining buffered istnic saline slutin. The blister is labeled with the base curve, diameter, diptric pwer, manufacturing lt number, and expiratin date f the lens. DO NOT USE IF THE BLISTER PACK IS BROKEN OR THE SEAL HAS BEEN DAMAGED REPORTING OF ADVERSE REACTIONS All serius adverse experiences and adverse reactins bserved in patients wearing any BIOFINITY cntact lens r experienced with the lenses shuld be reprted t: CARE FOR A DRIED OUT (DEHYDRATED) LENS If any BIOFINITY lens is expsed t air while ff the eye, it may becme dry and brittle. In this event, simply dispse f the lens and replace with a fresh ne. CARE FOR A STICKING (NONMOVING) LENS If the lens sticks (stps mving r cannt be remved), the patient shuld be instructed t apply 2 t 3 drps f the recmmended lubricating r rewetting slutin directly t the eye and wait until the lens begins t mve freely n the eye befre remving it. If nnmvement f the lens cntinues mre than 5 minutes, the patient shuld immediately cnsult the Eye Care Practitiner. EMERGENCIES The patient shuld be infrmed that if chemicals f any kind (husehld prducts, gardening slutins, labratry chemicals, etc.) are splashed int the eyes, the patient shuld: FLUSH THE EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT Part Number: LF0125D Rev Date: December 2014 Attn: Prduct Services 711 Nrth Rad Scttsville, New Yrk (800) Hamble, Suthamptn, SO31 4RF, UK