PACKAGE INSERT

MOODY Spherical Daily Wear Soft (hydrophilic) Contact Lenses 

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

IMPORTANT

Please read carefully and keep this information for future use. This package insert is intended for the eyecare practitioner but should be made available to the patient upon request. The eyecare practitioner should provide the patient with the wearer’s guide that pertains to the patient’s prescribed lens.

DESCRIPTION

The moody Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The lenses are fabricated from polymacon. 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).  

MOODY lenses are available cosmetically tinted. The 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, MICA.    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 cosmetically 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 6.0 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:

The hydrophilic characteristics allow the 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:

ACTIONS

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

CAUTION

Due to the small number of patients enrolled in the clinical investigation of lens, all refractive powers, design configurations, or lens parameters available in the lens material are 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.

INDICATIONS

The moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses 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 astigmatism does not interfere with visual acuity.  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 disinfecting system.

CONTRAINDICATIONS (REASONS NOT TO USE)

DO NOT USE the moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses when any of the following conditions are present:

* Acute and subacute inflammation or infection of the anterior chamber of the eye.

* Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.

* Severe insufficiency of lacrimal secretion (dry eyes).

* Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.

* Any systemic disease that may affect the eye or be exaggerated by wearing a contact lens.

* Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.

* Allergy to any ingredient, such as mercury or thimerosal, in a solution that is to be used to care for the moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses.

* Any active corneal infection (bacterial, fungi, or viral)

* If eyes become red or irritated.

* Patients unable to follow lens care regimen or unable to obtain assistance to do so.

WARNINGS

PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS

COULD RESULT IN SERIOUS INJURY TO THE EYE.

Patients wearing lenses on a frequent/planned replacement schedule should not reuse or “top off” old solution left in the lens case since solution reuse reduces effective lens disinfection and could lead to severe infection, vision loss or blindness. “Topping-Off” is the addition of fresh solution to solution that has been sitting the case.

When disinfecting frequent/planned replacement lenses the patient should rub and rinse the lenses for the recommended amount of time to help prevent serious eye infections (see the frequent/planned replacement wearer’s instruction guide for detailed instructions).

The patient should never use water, saline solution, or rewetting drops to disinfect the lenses. These solutions will not disinfect the lenses. Not using the recommended disinfectant can lead to severe infection, vision loss or blindness.

Patients should not store their lenses or rinse their lens case with water or any non-sterile solution. Patients wearing frequent/planned replacement lenses must only use fresh multi-purpose solution (or sterile saline solution) so their lenses or lens case are not contaminated. Use of non-sterile solution can lead to severe infection, vision loss or blindness.

Water can harbor microorganisms that can lead to severe infection, vision loss or blindness. If the patient’s lenses have been submersed in water such as when swimming in pools, lakes, or oceans the patient should discard them and replace them with a new pair. Patients should be instructed to ask their eye care practitioner (professional) for recommendations about wearing their lenses during any activity involving water.

Using the multi-purpose solution beyond the discard date could result in contamination of the solution and can lead to severe infection, vision loss or blindness.

EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF VISION; IF THE PATIENT EXPERIENCES:

• Eye Discomfort,
• Excessive Tearing,
• Vision Changes,
• Loss of Vision,
• Eye Redness
• Or Other Eye Problems

THE PATIENT SHOULD IMMEDIATELY REMOVE THE LENSES, AND PROMPTLY CONTACT THEIR EYE CARE PRACTITIONER.

Daily wear lenses are not indicated for overnight wear, and patients should be instructed not to wear lenses while sleeping.  Clinical studies have shown that the risk of serious adverse reactions is increased when these lenses are worn overnight.

Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers.

All contact lens wearers must see their eyecare practitioner as directed.

PRECAUTIONS

Special Precautions for the Eyecare Practitioner:

* Clinical studies have demonstrated that contact lens manufactured from (polymacon) are safe and effective for their intended use.  However, 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 are 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 should 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 eye care practitioner

* Fluorescein, a yellow dye, should not be used while the lens is on the eye.  The lens absorbs this dye and becomes discolored.  Whenever Fluorescein is used in the eyes, the eyes should be flushed with a sterile saline solution that is recommended for in-eye use.  Wait at least one hour before replacing the lens.  The too early replacement may allow the lens to absorb residual Fluorescein irreversibly.

* Before leaving the eyecare practitioner's office, the patient should be able to promptly remove the lens or should have someone else available who can remove the lens for him or her.

* Eyecare practitioners should instruct the patient to remove the lens immediately if the eye becomes red or irritated.

* The patient should be instructed to always discard disposable lenses and lenses worn on a frequent/planned replacement schedule after the recommended wearing schedule prescribed by the eye care professional.

PRECAUTIONS FOR FREQUENT/PLANNED REPLACEMENT WEAR

* Different solutions cannot always be used together, and not all solutions are safe for use with all lenses.  Use only recommended solutions that are fresh and sterile.  Never use solutions recommended for conventional hard contact lenses only.  Chemical disinfection solutions should not be used with heat unless specifically indicated on product labeling for use in both heat and chemical disinfection.  Always use FRESH, STERILE UNEXPIRED lens care solutions. Always follow directions in the package inserts for the use of contact lens solutions.  Sterile unpreserved solutions, when used, should be discarded after the time specified in the labeling directions. Do not use saliva or anything other than the recommended solution for lubricating or rewetting lenses.  Always keep the lens completely immersed in the recommended storage solution when the lens is not being worn (stored).  Prolonged periods of drying will damage the lens.  Follow the lens care directions for (Care for a Dried Out Dehydrated Dry Lens) if the lens surface does become dried out.

* Carefully follow the handling, insertion, removal, cleaning, disinfection, storing, and wearing instructions in the frequent/planned replacement patient instructions for the moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses and those prescribed by the eyecare practitioner.

PRECAUTIONS FOR FREQUENT/PLANNED REPLACEMENT AND DISPOSABLE WEAR

* If the lens sticks (stops moving) on the eye, follow the recommended directions on (care for sticking non-moving lens).  The lens should move freely on the eye for the continued health of the eye.  If nonmovement of the lens continues, the patient should be instructed to IMMEDIATELY consult his or her eyecare practitioner.

* Always wash and rinse your hands before handling the lens. Do not get cosmetics, lotions, soaps, creams, deodorants, or sprays in the eyes or on the lens.  It is best to put on a lens before putting on makeup.  Water-based cosmetics are less likely to damage lenses than oil-based.

* Do not touch the contact lens with the fingers or hands if the hands are not free of foreign materials, as microscope scratches of the lens may occur, causing distorted vision and/or injury to the eye.

* Never wear lenses beyond the period recommended by the eyecare practitioner.

* Water activity: The Patient should not expose their contact lenses to water while wearing them.

* If aerosol products such as hair spray are used while wearing lens, exercise caution and keep eyes closed until the spray has settled.

* Always handle lens carefully and avoid dropping them.

* Avoid all harmful or irritating vapors and fumes while wearing lens.

* Ask the eyecare practitioner about wearing lens during sporting activities.

* Inform the doctor (health care practitioner) about being a contact lens wearer.

* Never use tweezers or other tools to remove lens from the lens container unless specifically indicated for that use.  Pour the lens into the hand.

* Do not touch the lens with your fingernails.

* Always contact the eye care practitioner before using any medicine or medications in the eyes.

* Always inform the employer of being a contact lens wearer.  Some jobs may require use of eye protection equipment or may require that the patient not wear contact lens.

* As with any contact lens, follow-up visits are necessary to assure the continuing health of the patient's eyes.  The patient should be instructed as to a recommended follow-up schedule.

ADVERSE REACTIONS

The patient should be informed that the following problems may occur:

* Eyes stinging, burning, itching (irritation), or other eye pain.

* Comfort is less than when lens was first placed on the eye.

* Feeling that something is in the eye such as a foreign body or scratched area.

* Excessive watering (tearing) of the eye.

* Unusual eye secretions.

* Redness of the eye.

* Reduced sharpness of vision (poor visual acuity).

* Blurred vision, rainbows, or halos around objects.

* Sensitivity to light (photophobia).

* Dry eyes.

If the patient notices any of the above, he or she should be instructed to:

* IMMEDIATELY REMOVE THE LENS.

* For frequent/planned replacement wearers: if discomfort or problem(s) stops, then look closely at the lens.  If the lens is in any damage, DO NOT PUT THE LENS BACK ON THE EYE.  Place the lens in the storage case and contact the eyecare practitioner.  If the lens has dirt, an eyelash, or other foreign body on it, or the problem stops and the lens appears undamaged, the patient should thoroughly clean, rinse, and disinfect the lens and then reinsert them. After reinsertion, if the problem continues, the patient should IMMEDIATELY REMOVE THE LENS AND CONSULT THE EYECARE PRACTITIONER.  

When any of the above problems occur, a serious condition such as infection, corneal ulcer, neovascularization, or iritis may be present.  The patient should be instructed to KEEP LENS OFF THE EYE AND SEEK IMMEDIATE PROFESSIONAL IDENTIFICATION of the problem and prompt treatment to avoid serious eye damage.

FITTING

1. 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

2. Initial Lens Power Selection

   a) Convert the spectacle Rx to minus cylinder forms

   b)Compensate the spectacle Rx for vertex distance ifthe power is greater then + or – 4.00 diopters

   c)Drop the cylinder

   d)Add + 0.25 diopter to compensate for minus tear lens

   e)If refractive astigmatism exceeds 0.75 diopter, determine equivalent sphere and then compensate for power by adding +0.25 diopter for minus tear lens

1. Initial Lens Diameter and Base Curve Selection

The lens is currently offered in one diameter (14.50 mm) and one base curve (8.7)

2. Initial Lens Evaluation

    a) Check Lens Centration, Movement, and Size

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.

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.

   b) Refract Over the Lens and Determine Visual Acuity

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.

   c) Determine the Optical Power for the Lens Selected

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.

3. Follow-up Care

  a) Follow-up examinations, as recommended by the eyecare practitioner, are necessary to ensure continued successful contact lens wear.

  b) 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.

  c) 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.

  d) After the lens removal, conduct a thorough biomicroscopy examination.

1. 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.

WEARING SCHEDULE

THE WEARING AND REPLACEMENT SCHEDULES SHOULD BE DETERMINED BY THE EYECARE PRACTITIONER.  Patients tend to over-wear the lens initially.  The eyecare practitioner should emphasize the importance of adhering to the initial maximum wearing schedule.  Regular checkups, as determined by the eyecare practitioner, are also extremely important. 

The moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses are indicated for daily wear.  The maximum suggested wearing time for this lens is:

STUDIES HAVE NOT BEEN COMPLETED TO SHOW THAT moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses IS SAFE TO WEAR DURING SLEEP.

WEARING SCHEDULES SHOULD BE DETERMINED BY THE EYECARE PRACTITIONER.

LENS CARE DIRECTIONS

When lenses are dispensed, the patient should be provided with appropriate and adequate instructions and warnings for lens care handling.  The eye care professional should recommend procedures and products for each individual patient in accordance with their particular lens wearing schedule and care system selected by the practitioner, the specific instructions for such products and the particular characteristics of the patient.

Frequent/Planned Replacement: Eyecare practitioners should review with the patient lens care directions, including both basic lens care information and specific instructions on the lens care regimen recommended for the patient:

* Basic Instructions:

• Care of contact lens takes very little time and involves THREE essential steps – CLEANING, RINSING AND DISINFECTING.  Each step in itself is important, and one step is not to be replaced by the other.  
• Always wash, rinse and dry hands before handling contact lens.  
• Always use FRESH, STERILE UNEXPIREDlens care solutions.  
• Use the recommended lens care system; either chemical (not heat) or heat (thermal).
• Different solutions cannot always be used together, and not all solutions are safe for use with all lens.  
• DO NOT ALTERNATE OR MIX LENS CARE SYSTEMS UNLESS INDICATED ON SOLUTION LABELING.  
• Do not use saliva or anything other than the recommended solutions for lubricating or rewetting lens.  
• Do not put lens in the mouth.  
• Lens should be cleaned, rinsed, and disinfectedeach time they are removed.  
• Cleaning and rinsingare necessary to remove mucus and film from the lens surface.
• Disinfectingis necessary to destroy harmful germs.  
• The lens case must be emptied and refilled with fresh, sterile recommended storage and disinfection solution prior to disinfecting the lens.
• Eyecare practitioners may recommend a lubricating/rewetting solution, which can be used to wet (lubricate) lens while they are being worn to make them more comfortable.

Note: Some solutions may have more than one function, which will be indicated on the label.  Read the label on the solution bottle, and follow the instructions.

* Lens cleaning, disinfection, and storage:

Clean one lens first (always the same lens first to avoid mix-ups), rinse the lens thoroughly with recommended rinsing or disinfecting solution to remove the cleaning solution, mucus, and film from the lens surface, and put lens into correct chamber of the lens storage case.  Then repeat the procedure for the second lens.  After cleaning, disinfect lens using the system recommended by the manufacture and/or the eyecare practitioner. To store lens, disinfect and leave them in the closed/unopened case until ready to wear.  If lens is not to be used immediately following disinfection, the patient should be instructed to consult the package insert or the eyecare practitioner for information on storage of lens.  

* Lens Case Care:

Patients must rinse the lens case with sterile contact lens solution (never use tap water) and leave the lens case open to dry after each use. Turn the case over and shake any excess solution out of the case. Be sure that no residual solution remains in the case before the patient allows it to air dry.  Replace the lens case at least once every 3 months. Contact lens cases can be a source of bacterial growth.

* Lens Care Regimen:

Patients must adhere to the lens care regimen recommended by their eyecare practitioner for the moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses.  Failure to follow this procedure may result in development of serious ocular infections

* Care for a dried out (dehydrated) dry lens:

If for some reason, the lens dry out completely a minimum of handling is important, as they are very brittle in the dehydrated state.  Carefully place them in rinsing or storage solution for a minimum of thirty minutes during which time they will become soft and flexible.  Then follow the cleaning, rinsing, and disinfecting procedures - including soaking the lens in storage and disinfection solution for four hours before wearing again.

* Soaking and Storing the Lens:

Patients must only use fresh multi-purpose (contact lens disinfecting) solution each time when soaking (storing) the lenses. The moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses must be stored only in the recommended solutions.  If left exposed to the air, the lens will dehydrate.  If lens dehydrates, reference above section on caring for dried out (dehydrated) dry lens.

* Chemical (NOT HEAT) Lens Disinfection:

1. Wash and rinse hands thoroughly BEFORE HANDLING LENS.
2. After removal of lens, CLEAN the lens by applying three drops of cleaner to each surface.  Ruband rinse thelenses for 15-20 seconds or more and then repeat with the second side for a total of 2 times 30 seconds or more. Follow the complete recommended lens rubbing and rinsing times in the labeling to adequately disinfect the lenses and reduce the risk of contact lens infection.
3. AFTER CLEANING, thoroughly rinse both surfaces of the lens with a steady stream of fresh, sterile rinsing solution for approximately 10 seconds.
4. Fill contact lens carrying case with the recommended disinfection and storage solution and place lens in the proper cells and soak as recommend in solution labeling.

Note: DO NOT HEAT THE DISINFECTION SOLUTION AND LENS.

Caution: Lenses that are chemically disinfected may absorb ingredients from the disinfecting solution which may be irritating to the eyes.  A thorough rinse in fresh, sterile rinsing solution prior to placement on the eye should reduce the potential for irritation.

* Discard Date (for care products):

Discard any remaining solution ninety (90) days after opening.

CARE FOR A STICKING (NON-MOVING) LENS:

If the lens sticks (cannot be removed), the patient should be instructed to apply 3 to 4 drops of the recommended lubricating or rewetting solution directly to the eye and wait until the lens begins to move freely on the eye before removing it.  If non-movement of the lens continues after 15 minutes, the patient should IMMEDIATELY consult the eyecare practitioner.

HOW SUPPLIED:

The moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses are supplied sterile in:

• sealed blister packagescontaining a saline solution. The base of the package is made from polypropylene, which is covered with a laminated foil seal on top.  

or

• sealed glass vials containing a saline solution.  The glass vials are sealed with a silicone stopper.

The glass vials and 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.

REPORTING OF ADVERSE REACTIONS:

All serious adverse experiences and adverse reactions observed in patients wearing moody Spherical Daily Wear Soft (hydrophilic) Contact Lenses or experienced with the lens should be reported to [email protected]

Vision Science Co., Ltd.

37-38, Maeyeo-ro 1-gil

Dong-gu, Daegu, 712-852

South Korea 

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

REVISION DATE:  03/2023