Patient Instructions (Part 2) After Your TN (generic name) Rigid Gas Permeable Contact Lenses For Orthokeratology Have Been Fitted
Federal law prohibits dispensing without a prescription.
|WARNING:||Contains a [identify] compound which harms public health and environment by destroying ozone in the upper atmosphere.|
TABLE OF CONTENTS
Personal Cleanliness And Lens Handling
Preparing The Lens For Wearing
Handling The Lenses
Placing The Lens On The Eye
Centering The Lens
Removing The Lens
Caring For Your Lenses (Cleaning, Rinsing, Disinfecting, Enzyming, Storage And Rewetting/Lubricating)
Lens Deposits And Use Of Enzymatic Cleaning Procedures
Care For A Sticking (Nonmoving) Lens
Wearing and Appointment Schedules
Clinical studies have demonstrated that contact lenses manufactured from the TN (generic name) rigid gas permeable lens materials are safe and effective for their intended use. However, the clinical studies may not have included all design configurations or lens parameters that are presently available in the materials. Consequently, when selecting an appropriate lens design and parameter the eyecare practitioner should consider all factors that effect lens performance and ocular health. The potential impact of these factors should be weighed against the patient's needs; therefore, the continuing ocular health of the patient and lens performance on the eye should be carefully monitored.
Patients should be instructed to follow the instructions below in order to prevent damage to their eyes or lenses.
- Different solutions cannot always be used together, and not all solutions are safe for use with all lenses. Use only recommended solutions with the contact lenses.
- Do not heat the wetting/soaking solution and lenses.
- Always use fresh unexpired lens care solutions.
- Always follow directions in the package inserts of the contact lens solutions used.
- Use only a chemical lens care system. Use of a heat (thermal) lens care system can cause damage by warping TN contact lenses.
- 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 solutions for lubricating or wetting lenses.
- Always keep the lenses completely immersed in the recommended storage solution when the lenses are not being worn (stored).
Always wash and rinse 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-base cosmetics are less likely to damage lenses than oil-base products.
Be certain that your fingers or hands are free of foreign material before touching your contact lenses, as microscopic scratches of the lenses may occur, causing distorted vision and /or injury to the eye.
Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing and wearing instructions in this booklet and those prescribed by your eyecare practitioner.
Always handle your 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 your lens into your hand.
Do not touch the lens with your fingernails.
To minimize lens warpage during cleaning, the lenses should be cleaned in the palm of the hand rather than between the thumb and fingers.
Lens Wearing Precautions
If the lens sticks (stops moving) on the eye, follow the recommended directions on Care for a Sticking Lens in this booklet. The lens should move freely on the eye for the continued health of the eye. If nonmovement of the lens continues, you should immediately consult your eyecare practitioner.
Never wear your contact lenses beyond the period recommended by your eyecare practitioner.
Avoid, if possible, all harmful or irritating vapors and fumes when wearing lenses.
If aerosol products such as sprays are used while wearing lenses, exercise caution and keep eyes closed until the spray has settled.
Lens Case Precautions
Contact lens cases can be a source of bacterial growth. To prevent contamination and to help avoid serious eye injury, always empty and rinse the lens case with fresh, sterile rinsing solution and allow to air dry.
Lens cases should be replaced at regular intervals as recommended by the lens case manufacturer or eyecare practitioner.
Topics to Discuss with the Eyecare Practitioner
Ask your eyecare practitioner about wearing your lenses during sporting activities.
Always contact your eyecare practitioner before using any medicine in your eyes.
As with any contact lens, follow-up visits are necessary to assure the continuing health of your eyes. You should be instructed as to a recommended follow-up schedule.
Who Should Know That the Patient is Wearing Contact Lenses
Inform your doctor (health care practitioner) about being a contact lens wearer.
Always inform your employer of being a contact lens wearer. Some jobs may require the use of eye protection equipment or may require that you not wear contact lenses.
You 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 eye.
- Feeling of something in the eye such as a foreign body or 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 your eye. Place the lens in the storage case and contact your eyecare practitioner. If the lens has dirt, an eyelash, or other foreign objects on it, or the problem stops and the lens appears undamaged, you should thoroughly clean, rinse and disinfect the lens; then reinsert it. If the problem continues, you should IMMEDIATELY remove the contact lenses and consult your eyecare practitioner.
When any of the above problems occur, a serious condition such as infection, corneal ulcer, neovascularization, or iritis may be present. You should be instructed to keep the lens off the eye and seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage.
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 substance 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.
To avoid damaging your lenses, handle them with your fingertips, and be careful to avoid contact with your 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.
Develop the habit of always working with the same lens first to avoid mix-ups.
Remove the lens from its storage case and examine it to be sure that it is moist, clean, clear, and free of any nicks and tears.
Work over a table, upon which is placed a clean towel.
Do not place lenses on the eye while working over a sink.
For the right eye:
Wet the forefinger of the right hand and place the contact lens on the forefinger of the right hand.
Place the second finger of the left hand on the middle of the upper lid and press upward firmly.
Place the second finger of the right hand on the lower lid and press downward firmly.
Slowly move the hand to advance the forefinger with the contact lens towards the cornea until the lens touches the cornea and release the lids.
Release the lid and close the eye for a few seconds.
Repeat for the left eye.
There are other methods of lens placement. If the above method is difficult for you, your eyecare practitioner will provide you with an alternate method.
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 section in this booklet).
If the lens is centered, remove the lens (see "Removing the Lens" section and check for the following:
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 the procedure below.
First locate the lens by pulling away the lids. After the lens is found, gently press on the lid over the lens while looking away from the direction of the lens. Next look back towards the lens.
Always remove the same lens first.
For continued safe and comfortable wearing of your lenses, it is important that you clean and rinse, then disinfect your lenses after each removal using the care regimen recommended by your eyecare practitioner. Cleaning and rinsing are necessary to remove mucus, secretions, films, or deposits that may have accumulated during wearing. The ideal time to clean, rinse, and disinfect your lenses is immediately after wearing 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.
When you first receive your lenses, practice how to put the lenses on and removing them while you are in your eyecare practitioners 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 eyecare practitioner should instruct you about appropriate and adequate procedures and products for your use.
For safe contact lens wear, you should know and always practice your lens care routine:
Use the recommended system of lens care, which is chemical (not heat) and carefully follow instructions on solution labeling. Different solutions cannot always be used together, and not all solutions are safe for use with all lenses. Do not alternate or mix lens care systems unless indicated on solution labeling.
Always remove, clean, rinse, enzyme and disinfect your lenses according to the schedule prescribed by your eyecare practitioner. The use of an enzyme or any cleaning solution does not substitute for disinfection.
To avoid contamination, do not use saliva or anything other than the recommended solutions for lubricating or rewetting your lenses. Do not put lenses in your mouth.
The lens care products listed below are recommended by Applicant’s name for use with your TN orthokeratology contact lenses.
Chemical Lens Care System
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 instructions.
Enzyme cleaning may be recommended by your eyecare practitioner. Enzyme cleaning removes protein deposits on the lens. These deposits cannot be removed with regular cleaners. Removing protein deposits is important for the well-being of your lenses and eyes. If these deposits are not removed, they can damage the lenses and cause irritation.
Enzyme cleaning does not replace routine cleaning and disinfecting. For enzyme cleaning, you should carefully follow the instructions in the enzymatic cleaning labeling.
If the lens sticks (stops moving) or cannot be removed, you should apply 5 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 30 minutes, you should IMMEDIATELY consult your eyecare practitioner.
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into your eyes, you should: FLUSH EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT YOUR EYECARE PRACTITIONER OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.
Prescribed Wearing Schedule
PATIENT/EYECARE PRACTITIONER INFORMATION: