Paragon Vision Sciences Paraperm O2 pasifocon A User manual

Paraperm®O2(pasifocon A)
Rigid Gas Permeable Contact Lenses for Daily Wear
Instructions For Wearers

INSTRUCTIONS FOR WEARERS
Patient Name ____________________________________________
Date Dispensed ____________________________________________
Dispensed Lens
Lens Type Design
Daily Wear (DO NOT sleep in these lenses.)  Aspheric
 Bifocal
 Spherical
Material  Toric
 Paraperm®O2
Lens Prescription
Eye
Base Curve
Power
Diameter
Color
Lot Number
Right
Left
Prescribed By
Dr. __________________________________________________
Address __________________________________________________
__________________________________________________
Phone __________________________________________________
My cleaning and disinfecting system is:
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

Your Paraperm®rigid gas permeable contact lens may be tinted as a handling aid for locating the lens.
CAUTIONS: Federal (US) law restricts this device to sale by, or on the order of a licensed eye care
practitioner.
Nonsterile. Clean and condition prior to use.
NOTE: See the Package Insert for additional safety information.
WARNING: The eye care practitioner should provide this warning to the patient.
PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS
INJURY TO THE EYE. It is essential that you follow your eye care practitioner's directions and all labeling instructions
for proper use of your contact lenses and lens care products, including the lens case.
Patients should follow the complete recommended lens rubbing and rinsing times in the product labeling to adequately
disinfect their lenses and reduce the risk of contact lens contamination. Reduced rubbing or rinsing times may not
adequately clean their lenses.
Patients should fill their lens case with fresh solution every time they store their lenses, and never re-use solution. They
should discard their solution immediately after their lenses have been removed from the lens case. They should not store
their lenses in or rinse their lens case with tap water, bottled water or any non-sterile solution.
Patients should clean and rinse their lens case between uses as recommended by their eye care practitioner.
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF
VISION; THEREFORE, IF YOU EXPERIENCE EYE DISCOMFORT, EXCESSIVE TEARING, VISION
CHANGES, OR REDNESS OF THE EYE, OR OTHER PROBLEMS WITH YOUR EYES, IMMEDIATELY
REMOVE YOUR LENSES, AND PROMPTLY CONTACT YOUR EYE CARE PRACTITIONER.

INSTRUCTIONS FOR WEARERS
TABLE OF CONTENTS
Page
Introduction
1
Precautions
1
Adverse Effects (Problems And What To Do)
3
Personal Cleanliness And Lens Handling
4
Preparing The Lens For Wearing
4
Handling The Lenses
4
Placing The Lens On The Eye
4
Centering The Lens
5
Removing The Lens
5
Caring For Your Lenses
6
Basic Instructions
6
Lens Deposits And Use Of Enzymatic Cleaning Procedure
7
Care For A Sticking (Nonmoving) Lens
7
Emergencies
8
Wearing Schedule
8
Warning
9
How Supplied
9

INTRODUCTION
Your eyes need oxygen to stay healthy and to keep you seeing well and feeling well. But, unlike all the other
organs of your body, your eyes do not rely on the blood for oxygen. Instead they receive oxygen directly for
the air and from the tears that continually bathe them. That’s why it is important that today’s contact lenses
allow oxygen to pass through them so that the oxygen in the air can reach the eye’s tissues. Just as importantly,
contact lenses must be fitted properly by an eye care professional so that they will allow and, in fact, promote
the movement of oxygen-rich tears around and underneath them.
Your eye care professional can prescribe Paraperm®O2 (pasifocon A) rigid gas permeable contact lenses in a
variety of prescriptions and designs depending upon your vision correction needs. In addition, your eye care
professional will determine what type of wearing schedule is best suited for you.
Not all Paraperm®O2 rigid gas permeable contact lenses have been tested for safety in extended wear. The
following table summarized which lens designs are currently recommended for daily wear. For safe, successful
contact lens wear follow your eye care professional’s
recommended wearing schedule.
Lens Design
And Type*
Paraperm®O2
(pasifocon A)
Aspheric DW
yes
Bifocal DW
yes
Spherical DW
yes
Toric DW
yes
* DW = daily wear
PRECAUTIONS
Specific Precautions
•Clinical studies have demonstrated that Paraperm®O2(pasifocon A) rigid gas permeable contact lenses are
safe and effective for their intended use. Due to the small number of patients enrolled in clinical
investigation of lenses, all refractive powers, design configurations, or lens parameters available in the lens
materials were not evaluated in significant numbers. Consequently, when selecting an appropriate lens
design and parameters, the eye care practitioner must consider all factors 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 reduction; therefore, the continuing ocular health of the
patient and lens performance on the eye should be carefully monitored by the prescribing eye care
practitioner.

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•Patients should be instructed to follow the instructions below in order to prevent damage to their eyes or
lenses.
Solution Precautions
•Different solutions cannot always be used together, and not all solutions are safe for use with all lenses.
Use only recommended solutions with Paraperm®O2 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 Paraperm®O2contact lenses.
•Sterile unpreserved solutions, when used, should be discarded after the time specified in the labeling
directions.
•Do not use saliva, tap water 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).
Handling Precautions
•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 eye care 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 patient information 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 eye care
practitioner.

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•Never wear your contact lenses beyond the period recommended by your eye care 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 eye
care practitioner.
Topics To Discuss With The Eye Care Practitioner
•Ask your eye care practitioner about wearing your lenses during sporting activities.
•Always contact your eye care 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.
ADVERSE EFFECTS (PROBLEMS AND WHAT TO DO)
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 these problems, 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 eye care 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 eye care practitioner. 3

When any of the above problems occurs, a serious condition such as infection, corneal ulcer, neovascularization,
iritis, persistent stromal edema or GPC (giant papillary conjunctivitis) 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, including corneal scarring, opacification, blindness or loss of eye.
PERSONAL CLEANLINESS AND 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 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.
Handling The Lenses
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 or cracks.
Placing The Lens On The Eye
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 your right index finger with a drop of conditioning solution and place the contact lens front side down
on your right index finger.
•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.
•Stare into a mirror as though looking through the second finger holding the contact
•lens. You will later learn to do this without a mirror.
•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. 4

Repeat this procedure for the left eye.
There are other methods of lens placement. If the above method is difficult for you, your eye care practitioner
will provide you with an alternate method.
Note: If after placement of the lens your vision is blurred, check for the following:
1. The lens is not centered on the eye (see "Centering the Lens", next section in this
booklet).
2. If the lens is centered, remove the lens (see "Removing the Lens" section) and check for
the following:
a. Cosmetics or oils on the lens. Clean, rinse, disinfect, and place on the eye again.
b. The lens is on the wrong eye.
If you find that your vision is still blurred after checking the above possibilities, remove both
lenses and consult your eye care practitioner.
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 this procedure.
•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.
Removing The Lens
Always remove the same lens first.
•Wash, rinse, and dry your hands thoroughly.
•Work over a table with a clean towel. Do not remove lenses over a sink.
•Place the right index finger of the right hand at the outer corner of the eye.
•Place the left hand cupped below the eye.
•Open the eyes wide as if to stare.
•Continue to keep the eyes open and pull the lids sideways away from nose.
•Blink quickly and firmly.
Remove the second lens by following the same procedure.
5

Follow the required lens care procedures described under the heading: CARING FOR YOUR LENSES.
Note: If this method of removing your lens is difficult for you, your eye care practitioner
will provide you with an alternate method.
CARING FOR YOUR LENSES
Basic Instructions
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 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, 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 of the Package Insert.
When you first receive your lenses, practice how to put the lenses on and removing them while you are in your
eye care practitioner’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 your use.
For safe contact lens wear, you should know and always practice your lens care routine.
Always wash, rinse, and dry hands before handling contact lenses.
Always use fresh unexpired lens care solutions.
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 eye
care practitioner. The use of an enzyme or any cleaning solution does not substitute for disinfection.
To avoid contamination, do not use saliva, tap water or anything other than the recommended solutions for
lubricating or rewetting your lenses. Do not put lenses in your mouth.
Your eye care practitioner will recommend his/her preferred, FDA approved lens care solutions for the
cleaning, disinfection, storage and lubrication of your Paraperm® O2rigid gas permeable contact lenses.
Follow the instructions provided with each lens care solution. Failure to adhere to these procedures may result
in the development of serious ocular complications. A patient should not switch from one care system to
another unless the eye care practitioner has determined that this is necessary. Do not mix or alternate the
disinfection and storage systems unless so indicated on the product label.
1. Clean
Clean one lens first (always start with the same lens first to avoid mix-ups). Place the lens, front side down, in
the palm of the hand and apply several drops of cleaning solution. Using the index finger of the other hand,
apply slight pressure in a swirling motion for the time recommended by the cleaning solution manufacturer. Do
not clean the lens by rubbing it between the thumb and index fingers, as this may cause lens warpage. Patients
should follow the complete recommended lens rubbing and rinsing times in the product labeling to adequately
disinfect their lenses and reduce the risk of contact lens contamination. Reduced rubbing or rinsing times may
not adequately clean their lenses.

2. Rinse
Rinse the lens thoroughly as recommended by your lens care product manufacturer to remove the cleaning
solution, mucus, and film from the lens surface. Place that lens into the correct chamber of the lens storage
case. Then repeat the procedure for the second lens.
3. Disinfect
After cleaning and rinsing the lenses disinfect them by using the system recommended by your eye care
practitioner and/or the lens manufacturer. Follow the instructions provided in the disinfection solution labeling.
4. Storage
To store lenses, disinfect and leave them in the closed case until ready to wear. If lenses are not to be used
immediately following disinfection, you should consult the storage solution package insert or your eye care
practitioner for information on storage of your lenses.
Always keep your lenses completely immersed in a recommended disinfecting/conditioning solution when the
lenses are not being worn. If you discontinue wearing your lenses, but plan to begin wearing them again after a
few weeks, ask your eye care practitioner for a recommendation on how to store your lenses.
Note: Paraperm® O2contact lenses cannot be heat (thermally) disinfected.
5. Care of Your Lens Case
Contact lens cases can be a source of bacteria growth. After removing your lenses from the lens case, empty
and rinse the lens storage case with solution(s) recommended by the lens case manufacturer; then allow the lens
case to air dry. When the case is used again, refill it with fresh disinfecting solution. Lens cases should be
replaced at regular intervals as recommended by the lens case manufacturer or your eye care practitioner.
6. Lubricating/Rewetting
Your eye care practitioner will recommend a lubricating/rewetting solution for your use. Lubricating/Rewetting
solutions can be used to rewet (lubricate) your lenses while you are wearing them to make them more
comfortable.
Lens Deposits And Use Of Enzymatic Cleaning Procedure
Enzyme cleaning may be recommended by your eye care 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.
Care For A Sticking (Nonmoving) Lens
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 nonmovement of the lens continues after 30 minutes, you should IMMEDIATELY
consult your eye care practitioner.

7
EMERGENCIES
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.
•REMOVE YOUR LENSES.
•IMMEDIATELY CONTACT YOUR EYE CARE PRACTITIONER OR VISIT A HOSPITAL
EMERGENCY ROOM WITHOUT DELAY.
WEARING SCHEDULE
THE WEARING SCHEDULE SHOULD BE DETERMINED BY THE EYE CARE PRACTITIONER. People
tend to overwear contact lenses initially. It is important to adhere to the initial wearing schedule and never wear
your lenses beyond the maximum recommended hours. Regular checkups, as determined by the eye care
practitioner, are also very important.
NOTE: Paraperm®O2contact lenses should be only worn on a daily wear schedule.
DO NOT sleep in these lenses.
The maximum suggested wearing times for Paraperm® O2rigid gas permeable contact lenses are indicated in
the following tables.
Wearing Schedule For Daily Wear
DAY
1
2
3
4
5
6
7
8
9
10-14
15
and after
ALLOWED
HOURS
3
4
5
6
7
8
9
10
11
12
ALL daylight
hours as
needed
HOURS
WORN
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WARNING
It is recommended that contact lens wearers see their eye care practitioner twice each year or, if directed, more
frequently.
HOW SUPPLIED
Each Paraperm® O2lens is supplied nonsterile in an individual plastic case. The lens is shipped dry.
Manufacturer:
Paragon Vision Sciences, Inc. 1-800-528-8279
947. E Impala Avenue 1-480-892-7602
Mesa, Arizona 85204-6619 1-480-926-7369 FAX
ZQF020002E- 11/18
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