Hush Hush | Dune Gift Set | 1 Day, 30 pcs

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 info@moody-lenses.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.

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Package insert for

moody Color (polymacon) Soft (hydrophilic) Contact Lens 1 Day

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.

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.

2. DESCRIPTION

moody Color (polymacon) Soft (hydrophilic) Contact Lens 1 Day 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 polymer and 0.1 % trehalose.

moody Color (polymacon) Soft (hydrophilic) Contact Lens 1 Day are hemispherical shells of the following parameters:

The physical/optical properties of the Lens are:

1. 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.
2. 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.
3. The UV lenses (moody 38 UV 1 Day).

* The data was obtained from measurements taken through the central 3-5 mm portion of the thinnest marketed version of the UV lens (-3.00 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 1 Day acts as refracting media to focus light rays on the retina. The UV absorbing monomer in moody Color (polymacon) Soft (hydrophilic) Contact Lens 1 Day 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

moody Color (polymacon) Soft (hydrophilic) Contact Lens 1 Day is indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -0.00 to -20.00 diopters. 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 1 Day also helps protect against the transmission of harmful UV radiation to the cornea and into the eye.

5. CONTRAINDICATIONS (REASONS NOT TO USE)

Do not use the moody Color (polymacon) Soft (hydrophilic) Contact Lens 1 Day 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 1 Day.
• Any active corneal infection (bacterial, fungal, or viral).
• If eyes become red or irritated. 

6. WARNINGS

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 1 Dayand 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, or 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 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.

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 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. WEARING SCHEDULE

The moody Color (polymacon) Soft (hydrophilic) Contact Lens 1 Day is indicated for daily wear single use only. The lenses are to be discarded upon removal. Therefore, no cleaning and disinfecting is required. 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 1 Day 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 1 Day is indicated for daily wear. The maximum suggested wearing time for the lens is:

11. LENS CARE DIRECTIONS

The moody Color (polymacon) Soft (hydrophilic) Contact Lens 1 Day is indicated for daily wear single use only. Therefore, no cleaning and disinfecting is required. Patients should always dispose of the lenses when they are removed and have replacement lenses or spectacles available.

12. 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. 

13. 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.

14. 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.

15. 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

16. 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.

YUNG SHENG OPTICAL CO., LTD

Manufacturer Address: No.8, Keya 2^nd Road, Daya District, Taichung 42881, Taiwan

www.hydron.com.tw

Revision Date: 03/2023