Information for Prescriber

CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PRACTICIONER.

TABLE OF CONTENT

Material Characteristics/Description of Lens

Actions

Indications

Special Precautions for the Eyecare Practitioners

Contraindications

Warnings

Precautions

Adverse reactions

Patient selection

Fitting procedure

Clinical assessment

Follow-up examinations

Frequent/Planned Replacement Lens Handling (in-office cleaning, disinfecting, and storage)

Lens care directions

Recommended wearing schedule

Monovision fitting guidelines Frequent/planned replacement recommended lens care products

Emergencies

Reporting of adverse reactions

How supplied

MATERIAL CHARACTERISTICS

The MISAKI (polymacon) Spherical and Toric Daily Wear Soft (hydrophilic) Contact Lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2- HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co- polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The (polymacon) name has been adopted by the United States Adopted Names Council (USAN).

MISAKI (polymacon) Spherical and Toric Daily Wear Soft (hydrophilic) Contact Lenses cosmetically tinted. Lenses are tinted with one or a combination of one or more of the following ‘listed’ color additives: D&C Red 17, D&C Violet 2, D&C Yellow 10, Titanium Dioxide, Iron Oxide (Red), [Phthalocyaninato(2-)] Copper, Phthalocyanine Green, Carbazole Violet, Reactive Blue 19, and C.I. Reactive black 5. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the ‘listed’ color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the cosmetic tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The cosmetic tinting pattern has a standard Clear Pupil diameter of 3.0 – 5.0 mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The physical properties of the lens are:

Refractive Index
1.43

Light Transmission (tinted)
greater than 96% (at clear region corresponding to pupil standard 6.0 mm diameter);
Opaque or 0-10% (at tinted region corresponding to iris)

Surface Character
hydrophilic

Water Content
38±2%

Specific Gravity
1.17 (hydrated)

Oxygen Permeability
9.5 x 10-11 (cm2/sec)(mlO2)/(ml x mmHg @ 35°C)) (revised Fatt method) The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in spherical and toric configurations with the following features and properties:

Chord Diameter:
12.80 mm to 15.00 mm

Center Thickness:
0.050 mm to 0.135 mm (varies with power)

Base Curve:
8.0 mm to 9.0 mm

Power Range
Cast-molded:
10.00D to +10.00D in 0.25D steps
Lathe-cut:
20.00D to -10.00D & +20.00D to +10.00D in 0.25D steps
Cylinder Power (Toric):
0.25D to -3.00D in 0.25D steps (lathe-cut)
Cylinder Axis (Toric): 10° to 180° in 10° steps

ACTIONS

In its hydrated state, the MISAKI (polymacon) Spherical and Toric Daily Wear Soft (hydrophilic) Contact Lens, when placed on the cornea, act as a refracting medium to focus light rays on the retina.

INDICATIONS

Indications for use:

The MISAKI (polymacon) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The MISAKI (polymacon) Toric Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4.00 diopters. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

NOTE: See the WARNINGS reference to the relationship between lens wearing schedule and corneal complications.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

SPECIAL PRECAUTIONS FOR EYECARE PRACTITIONER

Due to the small number of patients enrolled in clinical investigation of lens, all refractive powers, design configurations, or lens parameters available in the lens material were not evaluated in significant numbers. Consequently, when selecting an appropriate lens design and parameters, the eyecare practitioner should consider all characteristics of the lens that can affect lens performance and ocular health, including oxygen permeability, wettability, central and peripheral thickness, and optic zone diameter.
The potential impact of these factors on the patient’s ocular health must be carefully weighed against the patient’s need for refractive correction. Therefore, the continuing ocular health of the patient and lens performance on the eye should be carefully monitored by the prescribing eyecare practitioner.

CONTRAINDICATIONS (REASONS NOT TO USE)

Please reference Contraindications (Reasons Not to Use) in the Package Insert included at the end of this Fitting Guide.

WARNINGS

Please reference Warnings in the Package Insert included at the end of this Fitting Guide.

PRECAUTIONS

Please reference Precautions in the Package Insert included at the end of this Fitting Guide.

ADVERSE REACTIONS

Please reference Adverse Reactions in the Package Insert included at the end of this Fitting Guide.

PATIENT SELECTION

Patient communication is vital. Patients who require visual correction but cannot adhere to the recommended care of the MISAKI (polymacon) Spherical and Toric Daily Wear Soft (hydrophilic) Contact Lenses should not be provided with this lens. All necessary steps in lens care and all precautions and warnings should be discussed and understood by the patient (Review Package Insert with patient).

FITTING PROCEDURE

1. Pre-fitting Examination
2. Initial lens power selection
3. Initial lens diameter and base curve selection
4. Initial lens evaluation
5. Follow-up care

FITTING PROCEDURE for the Spherical Single Vision Lens.

Pre-fitting Examination – A pre-fitting patient history and examination are necessary to: determine whether a patient is a suitable candidate for daily wear contact lenses (refer to contraindications) collect and record baseline clinical information to which post-fitting examination results can be compared make ocular measurements for initial contact lens parameter selection

Initial Lens Power Selection
Convert the spectacle Rx to minus cylinder forms Compensate the spectacle Rx for vertex distance if the power is greater then + or – 4.00 diopters Drop the cylinder Add + 0.25 diopter to compensate for minus tear lens If refractive astigmatism exceeds 0.75 diopter, determine equivalent sphere and then compensate for power by adding +0.25 diopter for minus tear lens

Initial Lens Diameter and Base Curve Selection The lens is currently offered in 3 diameters (14.00 / 14.20 / 14.50 mm) with 1 base curves (8.6mm)

Initial Lens Evaluation Check Lens Centration, Movement, and Size

1. The criteria for a well fit lens is one which centers easily after a blink, bridges the limbus and extends onto the sclera about 1.5 millimeters, lags downward about 1 to 2 millimeters on upward gaze, and does not move excessively as a result of blinking or exaggerated eye movements.
2. After the trial lens settled on the eye (5 – 10 minutes), manipulate the lens using lid pressure and observe for indications of excessive tightness. The lens should move freely and easily with the slightest pressure and return to the centered position when released.
3. Movement of the lens on the eye is very important in assessing the fit and performance of the lens. In primary gaze, slight vertical post-blinking lens movement should occur. On upward gaze, the lens should sag approximately 1 – 2 millimeters. Refract Over the Lens and Determine Visual Acuity
4. Allow approximately 10 minutes for fluid equilibration and patient adaptation prior to over refracting. Determine best visual acuity when final over refraction has been achieved. If good visual acuity cannot be obtained through the lens with spherocylindrical over refraction, re- evaluation of the physical fit should be considered. Trial lens procedure should be repeated with lenses of different base curves. Determine the Optical Power for the Lens Selected
5. When the proper physical fit has been determined, convert the over refraction through the diagnostic lens to equivalent sphere and add this to the power of the trail lens. This will provide the final power of the lens.

Follow-up Care

Follow-up examinations, as recommended by the eyecare practitioner, are necessary to ensure continued successful contact lens wear.
Prior to a follow-up examination, the contact lenses should be worn for at least one continuous hour and the patient should be asked to identify any problems which might be occurring related to contact lens wear.
With lenses in place on the eyes, evaluate fitting performance to assure that CRITERIA OF A WELL FITTED LENS continues to be satisfied. Examine the lenses closely for surface deposition and/or damage.
After the lens removal, conduct a thorough biomicroscopy examination. 1. The presence of vertical corneal striae in the posterior central cornea and/or cornea neovascularization is indicative of excessive corneal edema.
The presence of corneal staining and/or limbal-conjunctival hyperemia can be indicative of an unclean lens, a reaction to solution preservatives, excessive lens wear, and/or a poorly fitting lens. Papillary conjunctival changes may be indicative of an unclean and/or damaged lens. If any of the above observations are judged abnormal, various professional judgments are necessary to alleviate the problem and restore the eye to optimal conditions. If the CRITERIA OF A WELL FITTED LENS are not satisfied during any follow-up examinations, the patient should be re-fitted with a more appropriate lens.

FITTING PROCEDURE FOR THE MISAKI (TORIC)

Pre-fitting Examination – A pre-fitting patient history and examination are necessary to: Determine whether a patient is a suitable candidate for daily wear contact lens (refer to contraindications) Collect and record baseline clinical information to which post-fitting examination results can be compared Make ocular measurements for initial contact lens parameter selection

Initial Lens Power SelectionConvert the spectacle Rx to minus cylinder forms
Determine the cylinder axis – Available any axis (10˚ steps) Determine the cylinder power – Available powers are -0.50D/-0,75D/-1.00D/-1,25D/-1.50D-1,75D/- 2.00D/-2,25D/-2.50D/-2,75D/-3.00D Determine the sphere power
Compensate the spherical Rx for vertex distance of the power is greater than plus or minus 4.00 diopters
Add + 0.25 to sphere to compensate for the minus tear lens

Initial Lens Diameter and Base Curve SelectionThe lens is currently offered in 2 diameters (14.20 & 14.50 mm) with 3 base curves (8.6, 8.7, and 8.8MM)

Initial Lens Evaluation
Check Lens Centration, Movement, and Size

1. The criteria for a well fit lens is one which centers easily after a blink, bridges the limbus and extends onto the sclera about 1.5 millimeters, lags downward about 1 to 2 millimeters on upward gaze, and does not move excessively as a result of blinking or exaggerated eye movements.
2. After the trial lens settled on the eye (5 – 10 minutes), manipulate the lens using lid pressure and observe for indications of excessive tightness. The lens should move freely and easily with the slightest pressure and return to the centered position when released.
3. Movement of the lens on the eye is very important in assessing the fit and performance of the lens. In primary gaze, slight vertical post-blinking lens movement should occur. On upward gaze, the lens should sag approximately 1 – 2 millimeters. Refract Over the Lens and Determine Visual Acuity
4. Allow approximately 10 minutes for fluid equilibration and patient adaptation prior to over refracting. Determine best visual acuity when final over refraction has been achieved. If good visual acuity cannot be obtained through the lens with spherocylindrical over refraction, re- evaluation of the physical fit should be considered. Trial lens procedure should be repeated with lenses of different base curves. Lens Orientation Evaluation and Determination of Lens Axis
5. MISAKI (polymacon) Toric Daily Wear Soft (hydrophilic) Contact Lenses are marked at 6 o’clock for ease in properly orienting the lens and observing rotation.
6. With the trial lens settled on the eye (5-10 minutes), note the orientation of the toric lens marking relative to the vertical meridian. If the toric lens marking is not oriented at 6 o’clock, a common method of axis compensation is called “LARS” (Left Add, Right Subtract). On either eye, if the rotation is left to the examiner, note the amount of rotation in degrees, ADD it to the refractive cylinder axis and order the resulting axis. If the rotation is to the right of the examiner, note the amount of rotation in degrees, SUBTRACT it from the refractive cylinder axis and order the resulting axis.

Follow-up Care Follow-up examinations, as recommended by the eyecare practitioner, are necessary to ensure continued successful contact lens wear.
Prior to a follow-up examination, the contact lenses should be worn for at least one continuous hour and the patient should be asked to identify any problems which might be occurring related to contact lens wear.
With lenses in place on the eyes, evaluate fitting performance to assure that CRITERIA OF A WELL FITTED LENS continues to be satisfied. Examine the lenses closely for surface deposition and/or damage. Evaluate the orientation of the lens (note: the orientation of the prescribed lens should be the same as the orientation observed for the fitting. For example: if the lens marking rotated about 18° to the left during the fitting, the prescribed lens marking should also rotate about 18° to the left. After the lens removal, conduct a thorough biomicroscopy examination.

1. The presence of vertical corneal striae in the posterior central cornea and/or cornea neovascularization is indicative of excessive corneal edema.
2. The presence of corneal staining and/or limbal-conjunctival hyperemia can be indicative of an unclean lens, a reaction to solution preservatives, excessive lens wear, and/or a poorly fitting lens.
3. Papillary conjunctival changes may be indicative of an unclean and/or damaged lens.

If any of the above observations are judged abnormal, various professional judgments are necessary to alleviate the problem and restore the eye to optimal conditions. If the CRITERIA OF A WELL FITTED LENS are not satisfied during any follow-up examinations, the patient should be re-fitted with a more appropriate lens.

CLINICAL ASSESSMENT

Criteria of a Well-Fitted Lens

The criteria of a well fitted lens is one which centers easily after a blink, bridges the limbus and extends onto the sclera about 1.5 millimeters, lags downward about 1 to 2 millimeters on upward gaze, and does not move excessively as a result of blinking or exaggerated eye movements. After the trial lens settled on the eye (5 – 10 minutes), manipulate the lens using lid pressure and observe for indications of excessive tightness. The lens should move freely and easily with the slightest pressure and return to the centered position when released. Movement of the lens on the eye is very important in assessing the fit and performance of the lens. In primary gaze, slight vertical post-blinking lens movement should occur. On upward gaze, the lens should sag approximately 1 – 2 millimeters.

Characteristics of a Tight (Steep) Lens
A tight (steep) lens does not move easily on the cornea with slight pressure

Characteristics of a Loose (Flat) Lens
A loose (flat) lens sags more than 2.0 millimeters on upward gaze

FOLLOW-UP EXAMINATIONS

* Within one week of lens dispensing
* After three weeks of lens wear
* After seven weeks of lens wear
* After each six month period of lens wear.
At the follow-up examinations, the patient should report good subjective quality of vision. Adaptation to vision with MISAKI Soft Contact Lenses should occur almost immediately and should definitely be reported within the first (1 week) follow-up visit. At these follow-up visits the practitioner should:

1. Check distance and near acuity with lens in place.
2. Over-refract to verify lens prescription.
3. Observe the position of the lens on the cornea. The lens should be centered and move on upward gaze and with a blink.
4. Evert the lids to examine the tarsal conjunctiva and check for incidence of giant papillary conjunctivitis.
5. Remove the lens. Check corneal curvature. There should be no substantial changes in either meridian.
6. Perform a slit-lamp examination with and without Fluorescein. Check for corneal edema, corneal abrasion, vascularization, corneal infiltrates, and perilimbal injection. Reinsert the lens only after all residual Fluorescein has dissipated from the eye.
7. For frequent/planned replacement lenses, clean the lens with a prophylactic surfactant cleaner, and examine for deposits, foreign bodies or physical imperfections of the lens surface.

FREQUENT/PLANNED REPLACEMENT LENS HANDLING (IN-OFFICE CLEANING, DISINFECTION, AND STORAGE)

Wash and rinse hands thoroughly, making certain all soap residues have been rinsed away before drying with a lint-free towel. It is suggested to wet the lens while in the eye using wetting drops before removal. Always start with the right lens first in order to avoid mixing the lens. In removing the lens, try to avoid touching the inside (concave) surface of the lens. It is possible, though not likely, that the lens might be inside out; therefore, check the lens by placing it on the index finger and examine its profile. If the edges of the lens tend to point outward, the lens is inside out. After removing the lens from its container assure that it is clean, clear and wet. Each frequent/planned replacement MISAKI Soft Contact Lens received in the eye care practitioner’s office is received sterile in (1) a sealed blister pack with sterile saline solution containing preservative Polyhexamethylene Biguanide (PHMB); or (2) a glass vial with sterile saline solution containing preservative PHMB. Both blister and glass vial packages are labeled as to the parameters of the contained lens. To assure sterility, the blister pack or glass vial should not be opened until ready for use.

To open the blister pack, pull back on the top where indicated. Upon removing the top cover of the blister pack, the lens may be removed and is ready for use. To open the glass vial, pull back on the top where indicated. Upon removing the top silicone cover, the lens may be removed and is ready for use. Prior to reusing in a diagnostic procedure or before dispensing to a patient, the lens should be surfaced cleaned and disinfected.

Cleaning: A surfactant cleaner must be used with the frequent/planned replacement MISAKI Soft Contact Lens to ensure a clean lens surface. The manufacturer’s instruction for Opti-Free Daily Contact lens cleaner is as follows:

Directions for use: Place lens in the palm of your hand. Apply 1 or 2 drops of cleaner to each lens surface and gently rub with the forefinger of the opposite hand. Clean for about 15-20 seconds Rinse the lens thoroughly with sterile saline solution. DO NOT use water to rinse your lenses. After rinsing, place the lens in a storage case. Repeat the process with the other lens. Disinfect lenses as per manufacturer’s instructions.

Rinsing: Thoroughly rinse both surfaces of the lens with a steady stream of fresh, sterile rinsing or multipurpose solution.

Chemical (Not-Heat) Lens Care System: A sterile rinsing, storing and disinfecting multipurpose solution should be used to rinse and chemically disinfect frequent/planned replacement MISAKI Soft Contact Lenses. After cleaning the lens, rinse with a liberal amount of fresh multipurpose solution to remove loosened debris and traces of cleaner. The lens should then be placed in the plastic container supplied in a multi-purpose solution kit and filled with enough fresh disinfecting solution to completely submerge the lens. To ensure disinfecting, the lens must remain in the disinfecting solution for the recommended period of time as written on the multipurpose solution bottle. Before reinsertion, lens should be rinsed with fresh sterile rinsing solution.

Storage: The frequent/planned replacement MISAKI Soft Contact Lens must be stored in the recommended solutions. If exposed to the air, the lens will dehydrate. If a lens dehydrates, it should be soaked ONLY in a soft contact lens storage solution until it returns to a soft, supple state. It should not be put on an eye until it has been put through a complete disinfection cycle.

LENS CARE DIRECTIONS

Please reference LENS CARE DIRECTIONS in the Package Insert included at the end of this Professional Fitting Guide.

RECOMMENDED WEARING SCHEDULE

Close professional supervision is recommended to ensure safe and successful contact lens wear. If the patient complains of discomfort, decreased vision, ocular injection or corneal edema, the lens should be removed and the patient scheduled for examination. The problem may be relieved by putting the patient on a different wearing schedule or possibly by refitting the lens.

Patients tend to overwear the lens initially. It is important not to exceed the initial wearing schedule. Regular check-ups, as determined by the eyecare practitioner, are also extremely important. The maximum suggested wearing schedule for the MISAKI Soft Contact Lens is reflected below.

DAY	HOURS
1	6
2	8
3	10
4	12
5	14
6	All Waking Hours *

STUDIES HAVE NOT BEEN COMPLETED TO SHOW THAT THE MISAKI Soft Contact Lens IS SAFE TO WEAR DURING SLEEP.

MONOVISION FITTING GUIDELINES PATIENT SELECTION

Monovision Needs Assessment

For a good prognosis the patient should have adequately corrected distance and near visual acuity in each eye. The amblyopic patient or the patient with significant astigmatism (greater than 1.50 diopter) in one eye may not be a good candidate for monovision with the MISAKI (polymacon) Spherical and Toric Daily Wear Soft (hydrophilic) Contact Lenses.
Occupational and environmental visual demands should be considered. If the patient requires critical vision (visual acuity and stereopsis) it should be determined by trial whether this patient can function adequately with monovision. Monovision contact lens wear may not be optimal for such activities as:

1. Visually demanding situations such as operating potentially dangerous machinery or performing other potentially hazardous activities;and
2. Driving automobiles (e.g., driving at night). Patients who cannot pass their state drivers license requirements with monovision correction should be advised to not drive with this correction, OR may require that additional over-correction be prescribed.

Patient Education All patients do not function equally well with monovision correction. Patients may not perform as well for certain tasks with this correction as they have with bifocal reading glasses. Each patient should understand that monovision, as well as other presbyopic contact lenses, or other alternative, can create vision compromise that may reduce visual acuity and depth perception for distance and near tasks. During the fitting process it is necessary for the patient to realize the disadvantages as well as the advantages of clear near vision in straight ahead and upward gaze that monovision contact lenses provide.

EYE SELECTION

Generally, the non-dominant eye is corrected for near vision. The following test for eye dominance can be used.

Ocular Preference Determination Methods Method 1—determine which eye is the “sight eye”. Have the patient point to and object at the far end of the room. Cover one eye. If the patient is still pointing directly at the object, the eye being used is the dominant (sighting) eye. Method 2—Determine which eye will accept the added power with the latest reduction in vision. Place a trial spectacle near add lens in front of one eye and then the other while the distance refractive error correction is in place for both eyes. Determine whether the patient functions best with the near add lens over the right or left eye.

Refractive Error Method For anisometropic corrections, it is generally best to fit the more hyperopic (less myopic) eye for distance and the more myopic (less hyperopic) eye for near.

Visual Demands Method Consider the patient’s occupation during the eye selection process to determine the critical vision requirements. If a patient’s gaze for near tasks is usually in one direction correct the eye on that side for near.

SPECIAL FITTING CONSIDERATIONS

Unilateral Lens CorrectionThere are circumstances where only one contact lens is required. As an example, an emmetropic patient would only require a near lens while a bilateral myope may require only a distance lens. Example:

1. A presbyopic emmetropic patient who requires a +1.75 diopter add would have a +1.75 lens on the near eye and the other eye left with a lens.
2. A presbyopic patient requiring a +1.50 diopter add who is -2.50 diopters myopic in the right eye and -1.50 diopters myopic in the left eye may have the right eye corrected for distance and the left uncorrected for near

NEAR ADD DETERMINATION

Always prescribe the lens power for the near eye that provides optimal near acuity at the midpoint of the patient’s habitual reading distance. However, when more than one power provides optimal reading performance, prescribe the least plus (most minus) of the powers.

TRIAL LENS FITTING

A trial fitting is performed in the office to allow the patient to experience monovision correction. Lenses are fit according to the directions in the general fitting guidelines and base curve selection described earlier in the guide.
Case history and standard clinical evaluation procedure should be used to determine the prognosis. Determine which eye is to be corrected for distance and which eye is to be corrected for near. Next determine the near add. With trial lenses of the proper power in place observe the reaction to this mode of correction.
Immediately after the correct power lenses are in place, walk across the room and have the patient look at you. Assess the patient’s reaction to distance vision under these circumstances. Then have the patient look at familiar near objects such as a watch face or fingernails. Again assess the reaction. As the patient continues to look around the room at both near and distance objects, observe the reactions. Only after these vision tasks are completed should the patient be asked to read print. Evaluate the patient’s reaction to large print (e.g. typewritten copy) at first and then graduate to news print and finally smaller type sizes.
After the patient’s performance under the above conditions are completed, tests of visual acuity and reading ability under conditions of moderately dim illumination should be attempted. An initial unfavorable response in the office, while indicative of a guarded prognosis, should not immediately rule out a more extensive trial under the usual conditions in which a patient functions.

ADAPTATION

Visually demanding situations should be avoided during the initial wearing period. A patient may at first experience some mild blurred vision, dizziness, headaches, and a feeling of slight imbalance. You should explain the adaptation symptoms to the patient. These symptoms may last for a brief minute or for several weeks. the longer these symptoms persist, the poorer the prognosis for successful adaptation.
To help in the adaptation process the patient can be advised to first use the lenses in a comfortable familiar environment such as in the home.
Some patients feel that automobile driving performance may not be optimal during the adaptation process. This is particularly true when driving at night. Before driving a motor vehicle, it may be recommended that the patient be a passenger first to make sure that their vision is satisfactory for operating an automobile. During the first several weeks of wear (when adaptation is occurring), it may be advisable for the patient to only drive during optimal driving conditions. After adaptation and success with these activities, the patient should be able to drive under other conditions with caution.

OTHER SUGGESTIONS

The success of the monovision technique may be further improved by having your patient follow the suggestions below.

1. Having a third contact lens (distance power) to use when critical distance viewing is needed.
2. Having a third contact lens (near power) to use when critical near viewing is needed.
3. Having supplemental spectacles to wear over the monovision contact lenses for specific visual tasks may improve the success of monovision correction. this is particularly applicable for those patients who cannot meet state licensing requirements with a monovision correction.
4. Make use of proper illumination when carrying out visual tasks. Success in fitting monovision can be improved by the following suggestions:
5. Reverse the distance and near eyes if a patient is having trouble adapting.
6. Refine the lens powers if there is trouble with adaptation. Accurate lens power is critical for presbyopic patients.
7. Emphasize the benefits of the clear near vision in straight ahead and upward gaze with monovision.
   * The decision to fit a patient with a monovision correction is most appropriately left to the eyecare practitioner in conjunction with the patient after carefully considering the patient’s needs.
   * All patients should be supplied with a copy of the MISAKI (polymacon) Soft Contact Lens Patient Instruction / Wearer’s Guide.

RECOMMENDED FREQUENT/PLANNED REPLACEMENT LENS CARE PRODUCTS

The eyecare practitioner should recommend a care system that is appropriate for the frequent/planned replacement MISAKI Soft Contact Lens. Each lens care product contains specific directions for use and important safety information, which should be read and carefully followed. The table below shows solutions that are recommended for use with the MISAKI Soft Contact Lens. Daily Cleaner: Renu Advanced Formula Multi-Purpose Solution by Bausch+Lomb” Rinsing Solution: Renu Advanced Formula Multi-Purpose Solution by Bausch+Lomb”

EMERGENCIES

The patient should be informed that if chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT THE EYECARE PRACTITIONER OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.

REPORTING OF ADVERSE REACTIONS

Practitioners should report any adverse reactions to MISAKI Soft Contact Lens within 5 days to Initial US Importer (TO BE DETERMINED). Additional Fitting Guides, Package Inserts and Patient Guides are available from:

www.misakicon.com/professional-fitting 

AZ & LINK ENTERPRISES PTE LTD

2 YISHUN INDUSTRIAL STREET 1
#02-29 , NORTHPOINT BIZHUB
SINGAPORE 768159
Tel: +1-855-855-5151

HOW SUPPLIED

The MISAKI Soft Contact Lenses are supplied sterile in either a sealed vial package or sealed blister packages containing saline solution. The base of the package is made from polypropylene, which is covered with a laminated foil seal on top.
The blister packages are marked with the base curve, diameter, dioptric power, toric cylinder power, toric cylinder axis, lens color, manufacturing lot number, and expiration date of the lens.