Polar Glacier | 6 Months, 2 pcs
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Replacement Cycle: Half Yearly Disposable
Diameter: 14.3mm
Graphic Diameter: 13.2mm
Base Curve: 8.8mm
Water Content: 38%
Material: polymacon
Packaging: 1 Piece/Box * This item is sold by pair / 2 pieces.
Delivery Time
Estimated delivery time is 10-15 business days, varying by destination country. For more details, please check shipping policy.
Tracking information will only be updated once the parcel arrives in United States (up to 7 business days after you receive order confirmation email).
Shipping Range
We currently ship to United States on moodylenses.com/us. For Singapore, please visit moodylenses.com/sg. For rest of world, please visit moodylenses.com.
Order Cancellation Refund Policy
If your order has not been processed, you can cancel the order within 2 hours via email to our customer service at support@moodylenses.com with your order number, contact info, and reasons to cancel.
Return Refund Policy
If your order has been processed, we provide return and refund service under the following conditions:
1. Please contact our customer service within 14 days upon receiving the package if you wish to return items (date of arrival according to tracking information).
2. Returned items must be unopened and in good condition.
3. We do not accept items that are damaged, opened, used, or expired. It is the customers' responsibility to cover the return shipping cost.
Before Wearing
For non-daily disposable, soak the lenses in multi-purpose solution for at least 8 hours before the first time wearing
Wash and dry your hands
Rinse contact lens with a fresh solution
Check the shape of the lens to ensure it has not turned inside out
How to Wear
Wash your tools
Use tweezers to pick up the lens
Put the lens on applicator
Place the lens in your eye
How to Remove
Ensure your hands are clean
Bring your index finger to your eye
Gently squeeze the lens between your thumb and index finger and remove it
How to Maintain
Wash your hands
Rub and clean your lens
Rinse fresh solution before using
Soak your lens in fresh solution after using
Package insert for
moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
IMPORTANT: Please read carefully and keep this information for future use. This package insert is intended for the eye care practitioner but should be made available to patients upon request. The eye care practitioner should provide the patient with the patient instructions that pertain to the patient’s prescribed lens.
The following symbols may appear on the label or carton
Symbol |
Definition |
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Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed practitioner |
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See Instructions for Wearers |
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Use by Date (expiration date) |
|
Batch Code |
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Sterile using Steam Heat |
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Manufacturer |
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Package material and recycling symbol |
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Lens contains UV blocking monomer |
PWR |
Power (in diopters) for contact lens |
BC |
Base Curve |
DIA |
Diameter |
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PRACTITIONER.
1. GLOSSARY OF TERMS
Words that are explained below are identified at each occurrence in the text by highlighting with bolding.
Terms |
Definition |
Adnexa |
The tissue surrounding the eyeball. |
Ametropia (myopia) |
Nearsightedness. A condition where the eyeball is too long and steep so that light rays focus before they reach the retina. The result is difficulty in seeing distant objects clearly. |
Anterior chamber |
The anterior chamber (AC) is the fluid-filled space inside the eye between the iris and the cornea's innermost surface. |
Aphakic |
Absence of the crystalline lens of the eye. |
Aspheric lens/Asphere |
Contact Lens with its front or back optic zone of aspheric form. |
Astigmatism |
A condition where the cornea is irregularly shaped, causing distorted vision, especially at near distances. |
Conjunctiva |
The membrane lines the inside of the eyelids and covers the sclera (white part of the eye). |
Cornea |
The cornea is the transparent front part of the eye that covers the iris, pupil, and anterior chamber. |
Corneal ulcer |
A corneal ulcer is an open sore or lesion on the cornea. |
Daily wear |
Worn during waking hours and removed at the end of each day for cleaning and disinfecting. |
Disinfection |
A process that kills harmful microorganisms (germs) which can cause serious eye infections. |
Iritis |
Inflammation of the colored part of the eye (Iris). |
Neovascularization |
Blood vessels growing into the cornea. |
Subacute inflammation |
Gradual swelling, redness, and pain. |
Ulcerative Keratitis |
An infected corneal ulcer. |
UV (ultraviolet) |
Light from the sun that can be harmful to the eye. |
2. DESCRIPTION
moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design.
The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The lenses contain a benzophenone UV-absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light. The average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 50 % in the UVA range of 316 to 380 nm. The lenses are dear or tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4 and printed with an intermittent coating containing a combination of the following approved pigments: Copper Phthalocyanine, Reactive Black 5, Iron Oxide, Titanium Dioxide, Carbazole Violet and D&C Yellow No. 10. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing 0.01 % sodium hyaluronate and 0.1 % trehalose.
moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear are hemispherical shells of the following parameters:
– Diameter: |
14.0 ± 0.2 mm |
– Basic Curve: |
8.6 ± 0.2 mm |
– Center Thickness: |
0.06 mm to 0.11 mm (varies with power) |
– Powers: |
-0.00 D to -20.00 D |
The physical/optical properties of the lens are:
– Refractive Index: |
1.440 ± 0.005 nd |
– Light Transmittance: |
> 95 % |
– Surface Character: |
Hydrophilic |
– Water Content: |
38 % |
– UV transmittance: |
UVB<5 %, UVA<50 % |
– Oxygen Permeability (Dk)*: |
13.5 ± 20% x 10-11 |
*(cm2/sec)(ml 02/ml x mmHg) 35°C (Polarographic method for determination of oxygen permeability) |
- Human cornea from a 24-year-old person as described in Lerman, S., Radiant Energy and the Eye, New York, 1980, p. 58, Figure 2-21.
- Human crystalline lens from a 25-year-old person as described in Waxler, M., Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 1986, p. 19, Figure 5.
- The UV lenses(moody 38 UV).
* The data was obtained from measurements taken through the central 3-5 mm portion of the thinnest marketed version of the UV lens (-12.00 D, 0.060 mm center thickness) and measured according to ISO 18369-3:2006 – Ophthalmic optical – Contact Lenses – Part 3: Measurement methods.
WARNING: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed.
3. ACTIONS
When placed on the cornea in its hydrated state, moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear acts as refracting media to focus light rays on the retina. The UV absorbing monomer in moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is used to block UV radiation. The average transmittance characteristics are less than 5 % in the UVB and less than 50 % in the UVA.
NOTE: Long-term exposure to UV radiation is one of the risk factors associated with cataracts. Exposure is based on a number of factors such as environmental conditions (altitude, geography, cloud cover) and personal factors (extent and nature of outdoor activities). UV-absorbing contact lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-absorbing contact lenses reduces the risk of developing cataracts or other eye disorders. Consult your eye-care practitioner for more information.
4. INDICATIONS FOR USE
The moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care professionals may prescribe the lens for daily disposable or daily wear in a Frequent Replacement Program (see Lens Replacement for a description of the wearing schedule). As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system.
5. CONTRAINDICATIONS (REASONS NOT TO USE)
Do not use moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear when any of the following conditions exist:
- Acute and subacute inflammationor 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 contact lenses.
- Allergic reactions of ocular surfaces or adnexathat may be induced or exaggerated by wearing contact lenses or the use of contact lens solutions.
- Allergy to any ingredient, such as mercury or thimerosal, in a solution, which is to be used to care for the moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear.
- Any active corneal infection (bacterial, fungal, or viral).
- If eyes become red or irritated.
6. WARNING
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 eye. Patients should be cautioned 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 keratitisis 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 keratitisis greater than among those who do not wear them overnight.
- The overall risk of ulcerative keratitismay be reduced by carefully following directions for lens care, including cleaning the lens case.
- Studies have shown that the risk of ulcerative keratitisamong contact lens users who smoke is greater than among non-smokers.
- If patients experience eye discomfort, excessive tearing, vision changes, redness of the eye, or other problems, they should be instructed to immediately remove their lenses and promptly contact their Eye Care Professional. It is recommended that contact lens wearers see their Eye Care Professional routinely as directed.
7. PRECAUTIONS
- Always wash and rinse your hands before handling lenses. Do not get cosmetics, lotions, soaps, creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses before putting on makeup. Water-based cosmetics are less likely to damage lenses than oil-based products.
- Be sure that before leaving the eye care professional’s office, the patient is able to remove lenses promptly or have someone else available to remove them.
- Be certain that the fingers or hands are free of foreign materials before touching lenses, as microscopic scratches of the lenses may occur, causing distorted vision and/or injury to the eye.
- Always handle lenses carefully and avoid dropping them.
- Do not touch the lens with your fingernails.
- Carefully follow the handling, insertion, removal, cleaning disinfecting, storing, and wearing instructions in the Patient Instruction Booklet for the moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wearand those prescribed by the eye care professional.
- Never use tweezers or other tools to remove lenses from the lens container unless specifically indicated for that use. Pour the lens into the hand.
- Contact lenses, even if worn for cosmetic reasons only, are prescription medical devices and must only be worn under the prescription, direction, and supervision of an eye care professional. The eye care professional needs to determine whether these lenses are appropriate for the individual patient and need to ensure proper fit on the patient’s individual eyes.
8. 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 the lens was first placed on the eye.
- Feeling that something is in the eye such as a foreign body or a scratched area.
- Excessive watering (tearing) of the eyes.
- Unusual eye secretions.
- Redness of the eyes.
- 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 THEIR LENSES.
- If the discomfort or the problem stops, then look closely at the lens. If the lens is in some way damaged, DO NOT PUT THE LENS BACK ON THE EYE. Place the lens in the storage case and contact the eye care 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 both lenses; then reinsert them. After reinsertion, if the problem continues, the patient should IMMEDIATELY REMOVE THE LENSES AND CONSULT THE EYE CARE 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 IMMEDIATELY REMOVE THE LENSES AND CONSULT THE EYE CARE PRACTITIONER. The patient should bring their lenses, solutions, and lens case with them to their eye care provider for culturing in order to better establish the identity of any organism associated with the patient’s infection.
9. FITTING PROCEDURE
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
a) Convert the spectacle Rx to minus cylinder forms
b)Compensate the spectacle Rx for vertex distance ifthe power is greater than + 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 diopters, determine the 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 diameter (14.0 ± 0.2 mm) and base curve (8.7± 0.2 mm).
Initial Lens Evaluation
a)Check Lens Centration, Movement, and Size
The criteria for a well-fit lens are 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.
The 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 sphere cylindrical over-refraction, re-evaluation of the physical fit should be considered. The 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 the equivalent sphere and add this to the power of the trail lens. This will provide the final power of the lens.
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 the 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.
- 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 is not satisfied during any follow-up examinations, the patient should be re-fitted with a more appropriate lens.
10. LENS REPLACEMENT / WEARING SCHEDULE
The wearing and replacement schedules should be determined by the eye care practitioner. Patients tend to over-wear the lenses initially. The eye care practitioner should emphasize the importance of adhering to the initial maximum wearing schedule. Regular checkups, as determined by the eye care practitioner are also extremely important.
Studies have not been conducted to show that moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is safe to wear during sleep, therefore patients should be advised to remove their lenses while sleeping. Normal daily wear of lenses assumes a minimum of 6 hours of non-lens wear per 24-hour period.
moody Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear. The maximum suggested wearing time for the lens is:
Day |
1 |
2 |
3 |
4 |
5 |
6 and after |
Hour |
4 |
6 |
8 |
10 |
12 |
all waking hours |
11. LENS CARE DIRECTIONS
I.Soaking and Storing Your Lenses
Instruction for Use:
- Use only fresh multi-purpose (contact lens disinfecting) solution each time you soak (store) your lenses.
WARNING:
- Do not reuse or “top off” old solution left in your 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 a fresh solution to a solution that has been sitting in your case.
II.Rub and Rinse Time
Instruction for Use:
- Rub and rinse your lenses for 10 seconds or more and then repeat with the second side for a total of 20 seconds.
- Follow the complete recommended lens rubbing and rinsing times in the labeling to adequately disinfect your lenses and reduce the risk of contact lens infection.
WARNING:
- Rub and rinse your lenses for the recommended amount of time to help prevent serious eye infections.
- Never use water, saline solution, or rewetting drops to disinfect your lenses. These solutions will not disinfect your lenses. Not using the recommended disinfectant can lead to severe infection, vision loss, or blindness.
III. Lens Case Care
Instruction for Use:
- Empty and clean your contact lens case with digital rubbing using fresh, sterile disinfecting solutions/contact lens cleaner after each use. Never use water.
- Rinse the case with fresh, sterile disinfecting solutions (never use water).
- Wipe the lens case dry with a fresh, clean, lint-free tissue.
- If you are air-drying your case, be sure that no residual solution remains in the case before allowing it to air dry. Never recap the lens case lids after use unless additional cleaning methods have been performed.
- Replace your lens case at least once every 3 months. Contact lens cases can be a source of bacterial growth.
WARNING:
- Do not store your lenses or rinse your lens case with water or any non-sterile solution. Only use fresh multi-purpose solution (or sterile saline solution) so you do not contaminate your lenses or lens case. The use of non-sterile solutions can lead to severe infection, vision loss, or blindness.
IV.Water Activity
Instruction for Use:
- Do not expose your contact lenses to water while you are wearing them.
WARNING:
- Water can harbor microorganisms that can lead to severe infection, vision loss, or blindness you’re your lenses have been submersed in water such as when swimming in pools, lakes, or oceans, you should discard them and replace them with a new pair. Ask your eye care practitioner (professional) for recommendations about wearing your lenses during any activity involving water.
V.Discard Date (for care products)
Instruction for Use:
- Discard any remaining solution 3 months after opening.
WARNING:
- Using your multi-purpose solution beyond the discard date could result in contamination of the solution and can lead to severe infection, vision loss, or blindness.
12. CHEMICAL LENS DISINFECTION (Including Hydrogen Peroxide):
- Cleanthe contact lenses with a recommended cleaning solution and thoroughly rinse them with a recommended rinsing solution.
- After cleaningand rinsing, to disinfect, carefully follow the instructions accompanying the disinfecting solution in the eye care regimen recommended by the lens manufacturer or the eye care practitioner.
- When using hydrogen peroxide lens care systems, lenses must be neutralized before Follow the recommendations on the hydrogen peroxide system labeling.
- Thoroughly rinse lenses with a fresh solution recommended for rinsing before inserting and wearing, or follow the instructions on the disinfection solution labeling.
- Do not heat the disinfection solution and lenses.
- Leave the lenses in the unopened storage case until ready to put on the eyes.
- CAUTION:Lenses that are chemically disinfected may absorb ingredients from the disinfecting solution which may be irritating to the eyes. A thorough rinse in a fresh sterile saline solution prior to placement in the eye should reduce the potential for irritation.
13. CARE FOR A DRIED-OUT (DEHYDRATED) LENS
If any lens is exposed to air while off the eye, it may become dry and brittle. In this event, simply dispose of the lens and replace it with a fresh one.
14. CARE FOR A STICKING (NONMOVING) LENS
If the lens sticks (stops moving or cannot be removed), the patient should be instructed to apply 2 to 3 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 the non-movement of the lens continues for more than 5 minutes, the patient should immediately consult the eye care practitioner.
15. 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 THE EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT THE EYE CARE PRACTITIONER OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.
16. HOW SUPPLIED
Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the color, base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens.
DO NOT USE IF THE BLISTER PACK IS BROKEN OR THE SEAL HAS BEEN DAMAGED
17. REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing any contact lens or experienced with the lenses should be reported to info@moody-lenses.com.
Manufacturer Address: No.8, Keya 2nd Road, Daya District, Taichung 42881, Taiwan
Revision Date: 03/2023