WEARING RESTRICTIONS AND INDICATIONS
The COLORCL Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of ametropia (myopia) in aphakic and non-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.
Eye Care professionals may prescribe the lens for daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
CONTRAINDICATIONS (REASONS NOT TO USE)
DO NOT USE the COLORCL Soft (hydrophilic) Contact Lens for Daily Wear when any of the following conditions exist:
- 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 contact lenses.
- 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, which is to be used to care for the COLORCL Soft (hydrophilic) Contact Lens for Daily Wear.
- Any active corneal infection (bacterial, fungal, or viral).
- If eyes become red or irritated.
You should be aware of and fully discuss with your eye care professional the following warnings pertaining to contact lens wear:
- Problems with contact lenses and lens care products could result in serious injury to your eye. You should know 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 contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers.
- You should know that when you wear your daily wear lenses overnight (outside the approved indication), the risk of ulcerative keratitis is greater than among those who do not wear them overnight.
- The overall risk of ulcerative keratitis may be reduced by carefully following directions for lens care, including cleaning the lens case.
- If you experience eye discomfort, excessive tearing, vision changes, redness of the eye or other problems, YOU SHOULD IMMEDIATELY REMOVE YOUR LENSES AND PROMPTLY CONTACT YOUR EYE CARE PROFESSIONAL.
- It is recommended that you see your Eye Care Professional routinely as directed.
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.
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.
- DO NOT use if the sterile blister package is opened or damaged.
- Before leaving the Eye care Professional’s office, you should be able to quickly remove your lenses or you should have someone else available who can remove the lenses for you.
- Always wash and rinse your hands before handling your lenses. Do not get cosmetics, lotions, soaps, creams, deodorants or sprays in your eyes or on your lenses. It is best to put on your lenses before putting on makeup. Water-based cosmetics are less likely to damage lenses than oil-based products.
- DO NOT touch your contact lenses with your fingers or hands if they are not completely clean, because tiny lens scratches may occur, causing unclear vision and/or injury to your eye.
- Carefully follow the handling, insertion, removal and wearing instructions in this booklet and those prescribed by the Eye care Professional.
- Always handle lenses carefully and avoid dropping them.
- Never use tweezers or other tools to remove your lenses from the lens container unless specifically indicated for that use. Pour the lens and the packing solution into the hand.
- Do not touch the lens with your fingernails.
Lens Wearing Precautions:
- You should remove your lenses immediately if your eyes become red or irritated.
- Never wear your lenses beyond the amount of time recommended by your Eye care Professional.
- If aerosol (spray) products, such as hair spray, are used while wearing lenses, exercise caution and keep your eyes closed until the spray has settled.
- Avoid all harmful or irritating vapors and fumes while wearing lenses.
- Ask your Eye care Professional about wearing contact lenses during sporting activities, especially swimming and other water sports. Exposing contact lenses to water during swimming or while in a hot tub may increase the risk of eye infection from germs.
- Always throw away lenses worn as prescribed by your Eye care Professional.
Lens Care Precautions:
- The Eye care Professional should review with the patient that no cleaning or disinfecting is needed with daily wear single use lenses. Patients should dispose of lenses when they are removed and have replacement lenses or spectacles available. Other Topics to discuss with Your Eye Care Professional:
- If you wear your contact lenses to correct presbyopia using monovision you may not be able to get the best corrected visual acuity for either far or near vision. Visual needs are different for different people, so your Eye care Professional should work with you when selecting the most appropriate type of lens for you.
- Always contact your Eye care Professional before using any medicine in your eyes.
- Be aware that if you use oral contraceptives (birth control pills), you could develop changes in vision or comfort when wearing contact lenses.
- As with any contact lens, follow-up visits are necessary to assure the continuing health of your eyes.
Who Should Know That You are Wearing Contact Lenses:
- Inform your doctor (Health care Professional) about being a contact lens wearer.
- Always inform your employer of being a contact lens wearer. Some jobs may require use of eye protection equipment or may require that you not wear contact lenses.
ADVERSE REACTIONS (PROBLEMS AND WHAT TO DO)
You should be aware 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 eye
• Abnormal feeling of something in the eye (foreign body, 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 you notice any of the above:
- Immediately remove your lenses.
- If the discomfort or problem stops, then look closely at the lens. If the lens is in any way damaged, DO NOT PUT THE LENS BACK ON THE EYE. Place the lens in the storage case and contact your eye care professional. If the lens has dirt, an eyelash, or other foreign body on it, or the problem stops and the lens appears undamaged, you should thoroughly clean, rinse, and disinfect both lenses; then reinsert them. After reinsertion, if the problem continues, you 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. You should IMMEDIATELY REMOVE THE LENSES AND CONSULT THE EYE CARE PRACTITIONER. You should bring your lenses, solutions and lens case with you to your eye care provider for culturing in order to better establish the identity of any organism associated with your infection.
PERSONAL CLEANLINESS FOR LENS HANDLING
- Preparing the Lens for Wearing:
It is essential that you learn and use good hygienic methods in the care and handling of your new lenses. Cleanliness is the first and most important aspect of proper contact lens care. In particular, your hands should be clean and free of any foreign substances when you handle your lenses. The procedures are:
- Always wash your hands thoroughly with a mild soap, rinse completely, and dry with a lint-free towel before touching your lenses.
- Avoid the use of soaps containing cold cream, lotion, or oily cosmetics before handling your lenses, since these substances may come into contact with the lenses and interfere with successful wearing.
- Handle your lenses with your fingertips, and be careful to avoid contact with fingernails. It is helpful to keep your fingernails short and smooth.
Start off correctly by getting into the habit of always using proper hygienic procedures so that they become automatic.
2. Handling the Lenses:
- Develop the habit of always working with the same lens first to avoid mixups.
- Remove the lens from its storage case and examine it to be sure that it is moist, clean, clear, and free of any nicks or tears.
- Should you accidentally place an inside-out lens on your eye, one of the following signs should signal you to remove and replace it correctly.
- Less than usual comfort
- The lens may fold on the eye
- Excessive lens movement on blink
- Blurred vision
- If the lens folds and sticks together: Place the lens in the palm of your hand and wet thoroughly with the recommended rinsing or storing solution.
- If this gentle rubbing does not work, soak the lens in the recommended solution in your lens case until the lens has resumed its normal shape. If the lens flattens or drapes across your finger, the lens or your finger may be too wet. To correct this, dry your finger by transferring the lens several times from one index finger to the other, drying the opposite finger each time.
- Keep the lens wet in the solution recommended by your eye care professional.
- Never place a lens on the eye unless it has been fully hydrated (wet) with the recommended rinsing or storing solution.
3. Placing the Lens on the Eye:
There are other methods of lens placement. If the following methods are difficult for you, your eye care professional will provide you with an alternate method.
Remember, always start with the same eye.
Once you have opened the lens package, removed and examined the lens, follow these steps to apply the lens to your eye:
- Place the lens on the tip of your index finger and check its profile. The lens should assume a natural, curved, bowl-like shape. If the lens edges tend to point outward, the lens is inside out. Another method is to gently squeeze the lens between the thumb and forefinger. The edges should turn inward. If the lens is inside out, the edges will turn slightly outward.
- Place the middle finger of the same hand close to your lower eyelashes and pull down the lower lid.
- Use the index finger or middle finger of the other hand to life the upper lid.
- Place the lens on the eye.
- Gently release the lids and blink. The lens will center automatically.
- Use the same technique when inserting the lens for your other eye.
Note: If after placement of the lens, your vision is blurred, check for the following:
- The lens is not centered on the eye (see "Centering the Lens," next in this booklet).
- If the lens is centered, remove the lens (see "Removing the Lens" section) and check for the following:
- Cosmetics or oils on the lens. Clean, rinse, disinfect, and place on the eye again.
- The lens is on the wrong eye.
- The lens is inside-out (it would also not be as comfortable as normal).
If you find that your vision is still blurred after checking the above possibilities, remove both lenses and consult your eye care professional.
4. Centering the Lens:
Very rarely, a lens that is on the cornea will be displaced onto the white part of the eye during lens wear. This can also occur during placement and removal of the lenses if the correct techniques are not performed properly. To center a lens follow one of the procedures below.
- Hold the upper and lower eyelids open with your fingers. Then, while looking in a mirror, gently place a finger on the contact lens and gently slide the lens towards the center of the eye.
5. Removing the Lens:
Always remove the same lens first.
- Wash, rinse, and dry your hands thoroughly.
- Always be sure that the lens is in the correct position on your eye before you try to remove it (a simple check of your vision, closing one eye at a time, will tell you if the lens is in the correct position). Look up and slowly pull down your lower lid with the middle finger of your removal hand and place your index finger on the lower edge of the lens. Squeeze the lens lightly between the thumb and index finger and remove it. Avoid sticking the edges of the lens together.
- Remove the other lens by following the same procedure.
- Follow the required lens care procedures described under the heading, CARING FOR YOUR LENSES (CLEANING, RINSING, DISINFECTING, ENZYMING, STORAGE AND REWETTING/LUBRICATING).
Note: If this method of removing your lens is difficult for you, your eye care professional will provide you with an alternate method.
CARING FOR YOUR LENSES (CELANING, RINISING, DISINFECTING, ENZYMING, STORAGE AND REWETTING/LUBRICATING)
1. Basic Instructions:
For continued safe and comfortable wearing of your lenses. It is important that you first clean and rinse, then disinfect [and neutralize (for hydrogen peroxide system)] your lenses after each removal, using the care regimen recommended by eye care practitioner. Cleaning and rinsing are necessary to remove mucus, secretions, films, or deposits which may have accumulated during wearing. The ideal time to clean your lenses is immediately after removing them. Disinfecting is necessary to destroy harmful germs.
You should adhere to a recommended care regimen. Failure to follow the regimen may result in development of serious ocular complications as discussed in the WARNINGS section above.
If you require only vision correction, but will not or cannot adhere to a recommended care regimen for your lenses, or are unable to place and remove lenses or have someone available to place and remove them, you should not attempt to get and wear contact lenses.
When you first get your lenses, be sure you have to put the lenses on and remove them while you are in your Eye care Professional’s office. At that time you will be provided with a recommended cleaning and disinfection regimen and instructions and warnings for lens care, handling, cleaning, and disinfection. Your eye care practitioner should instruct you about appropriate and adequate procedures and products for you use, and provide you with a copy of the Patient Instruction for the COLORCL Soft (hydrophilic) Contact Lens for Daily Wear.
For safe contact lens wear, you should know and always practice your lens care routine:
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.
- 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 fresh solution to solution that has been sitting 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.
- 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 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 < insert a recommended time period >. Contact lens cases can be a source of bacterial growth.
- 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. Use of non-sterile solution 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.
- 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.
- 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
2. Care for a Sticking (nonmoving) Lens:
If the lens sticks (stops moving or cannot be removed), you should 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 non-movement of the lens continues more than 5 minutes, you should immediately consult the eye care practitioner.
3. 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 with a fresh one.
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into your eyes: FLUSH EYES WITH TAP WATER AND IMMEDIATELY CONTACT YOUR EYE CARE PROFESSIONAL OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.
Please do not dispose of products such as contact lenses and blister labels until the problem is solved by COLORCL.
REPLACEMENT & SHELF LIFE OF COLORCL CONTACTS (EXP)
* Replacement: The maximum period during which the lens can be used from the day the blisters are opened.
* Shelf Life: Sterilization during which sterilization is effective from the day the lens is sterilized. Applicable only if blister have not been opened.
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