Bausch & Lomb PureVision2 Contact Lenses - Manual (Page 2)

CAUTION
Federal (U.S.A.) law restricts this device to sale by or on the order of a licensed
practitioner.
IMPORTANT
This package insert and fitting guide has been developed to provide practitioners
with information covering characteristics of the Bausch + Lomb PureVision ® 2
(balafilcon A) Visibility Tinted Contact Lens and to illustrate fitting procedures. It
is effective as of November 2013 and supersedes all prior fitting guides for the
product described. Please read carefully and keep this information for future use.
This package insert and fitting guide is intended for the eye care professional, but
should be made available to patients upon request. The eye care professional
should provide the patient with the patient instructions that pertain to the patient’s
prescribed lens and the recommended wearing schedule.
TAble Of CONTeNTs
Important 2
Description 3
Lens Parameters Available
4
How the Lens Works (Actions) 4
Indications 4
Contraindications (Reasons Not To Use)
6
Warnings 7
Precautions 9
Adverse Reactions
13
Clinical Studies 15
Selection of Patients 21
Fitting Procedure 21
Pre-Fitting Examination 21
Initial Lens Power Selection 22
Initial Lens Evaluation 22
Criteria of a Well-Fitted Lens 22
Characteristics of a Tight (Steep) Lens 22
Characteristics of a Loose (Flat) Lens 23
Follow-up Care 23
Practitioner Fitting Sets 24
Wearing Schedule 24
Monovision Fitting Guidelines 25
Patient Selection 25
Eye Selection 26
Special Fitting Considerations 26
Near Add Determination 27
Trial Lens Fitting 27
Adaptation 27
Other Suggestions 28
Handling of Lens 29
Patient Lens Care Directions 29
Frequent/Planned Replacement Wear 29
Disposable Wear 29
Therapeutic Wear 29
Care for a Sticking (Nonmoving) Lens 29
Reporting of Adverse Reactions 30
How Supplied 30
syMbOl RefeReNCe GUIde
For labels and cartons:
Quality System Certification Symbol
Fee Paid for Waste Management
Sterile Using Steam or Dry Heat
See Instruction Leaflet
Diameter
Use by Date (Expiration Date)
Batch Code
Authorized Representative in European Community
Caution: Federal law restricts this device to sale by or
on the order of a licensed practitioner
Diopter (Lens Power)
Base Curve
Storage Temperature
PACKAGE INSERT / FITTING GUIDE
© Bausch & Lomb Incorporated. All rights reserved worldwide.
®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates.
Other product/brand names are trademarks of their respective owners.
Name and Address of Manufacturer:
Bausch & Lomb Incorporated
Rochester, New York, USA 14609
Printed in the U.S.A.
SL7385-1
8067601
CAUTION: Federal law restricts this device to
sale by or on the order of a licensed practitioner.
desCRIPTION
The Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility Tinted Contact Lens is a
soft hydrophilic contact lens which is available as a spherical lens. The lens material,
balafilcon A, is a copolymer of a silicone vinyl carbamate, N-vinyl-pyrrolidone, a
siloxane crosslinker and a vinyl alanine wetting monomer, and is 36% water by
weight when immersed in a sterile borate buffered saline solution. This lens is tinted
blue with up to 300 ppm of Reactive Blue Dye 246.
The physical / optical properties of the lens are:
Specific Gravity:
1.064
Refractive Index: 1.426
Light Transmittance: C.I.E. value—at least 95%
Water Content: 36%
Oxygen Permeability: 91 x 10 –11 [cm 3 O
2
(STP) x cm]/(sec x cm 2 x mmHg)
@ 35° C Polarographic Method
(Boundary and Edge Corrected)
101 x 10 –11 [cm 3 O
2
(STP) x cm]/(sec x cm 2 x
mmHg) @ 35°C Polarographic Method
(Boundary Corrected, Non-Edge Corrected)
The Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility Tinted Contact
Lenses, with AerGel™ technology lens material, are manufactured by the
FormCast™ manufacturing process, cast molding process, and are surface
treated by the Performa™ surface treatment process which transforms
hydrophobic silicone to hydrophilic silicate.
The Bausch + Lomb PureVision
® 2 (balafilcon A) Visibility Tinted Contact Lens
may be prescribed for Frequent/Planned Replacement or Disposable Wear.
leNs PARAMeTeRs AVAIlAble
The Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility Tinted Contact Lens is a
hemispherical shell of the following dimensions:
Diameter: 14.0mm
Center Thickness: 0.05mm to 0.50mm
Base Curve: 8.6mm
Powers (Spherical): +6.00D to -12.00D*
* Additional powers may be introduced over time, check periodically for product availability.
HOW THe leNs WORKs (ACTIONs)
In its hydrated state, the Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility
Tinted Contact Lens when placed on the cornea acts as a refracting medium to
focus light rays on the retina. When placed on the cornea for therapeutic use,
the Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility Tinted Contact Lens
acts as a bandage to protect the cornea and relieve pain during treatment of
ocular pathologies.
INdICATIONs
Vision Correction
The Bausch + Lomb PureVision
® 2 (balafilcon A) Visibility Tinted Contact
Lens is indicated for daily wear or extended wear from 1 to 30 days between
removals, for cleaning and disinfection or disposal of the lens, as recommended
by the eye care professional. The lens is indicated for the correction of refractive
ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons
with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that
does not interfere with visual acuity. The lens may be prescribed for Frequent/
Planned Replacement Wear or Disposable Wear in spherical powers ranging
from +8.00D to -20.00D when prescribed for up to 30 days of extended wear
and from +20.00D to –20.00D for daily wear or extended wear up to 7 days.
Therapeutic Use
The Bausch + Lomb PureVision
® 2 (balafilcon A) Visibility Tinted Contact Lens
is also indicated for therapeutic use. Use as a bandage contact lens for corneal
protection and corneal pain relief during treatment of ocular pathologies as well
as post-surgical conditions. Applications of the Bausch + Lomb PureVision ® 2
(balafilcon A) Visibility Tinted Contact Lens include but are not limited to
conditions such as the following:
• For corneal protection in conditions such as entropion, trichiasis, tarsal
scars, recurrent corneal erosion and post surgical ptosis for corneal
protection;
• For corneal pain relief in conditions such as bullous keratopathy, epithelial
erosion and abrasion, filamentary keratitis, post-keratoplasty;
• For use as a bandage during the healing process of conditions such
as chronic epithelial defects, corneal ulcer, neurotrophic keratitis,
neuroparalytic keratitis, chemical burns, and post surgical epithelial
defects.
• For post-surgical conditions that include bandage use such as LASIK, PRK,
PK, PTK, lamellar grafts, corneal flaps, and additional corneal surgical
conditions.
Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility Tinted Contact Lenses for
therapeutic use can also provide optical correction during healing if required.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Bausch
+ Lomb PureVision ® 2 (balafilcon A) Visibility Tinted Contact Lens is to be
cleaned, rinsed and disinfected each time it is removed from the patient’s eye
and discarded after the recommended wearing period prescribed by the eye
care professional. The lens may be disinfected using a chemical disinfection
system.
Disposable Wear
When prescribed for Disposable Wear, the Bausch + Lomb PureVision
® 2
(balafilcon A) Visibility Tinted Contact Lens is to be discarded after each
removal.
CONTRAINdICATIONs
(ReAsONs NOT TO Use)
DO NOT USE the Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility Tinted
Contact Lens 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)
• Any systemic disease that may affect the eye or be exaggerated by wearing
contact lenses
• Allergic reactions of ocular surfaces or adnexa (surrounding tissue) 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 Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility
Tinted Contact Lens
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
WARNINGs
After a thorough eye examination, including appropriate medical background,
patients should be fully apprised by the prescribing professional of all the risks
with contact lens wear. Patients should be advised of the following warnings
pertaining to contact lens wear:
• Problems with contact lenses and lens care products could result in serious
injury to the eye. It is essential that patients follow their eye care professional’s
direction and all labeling instructions for proper use of lenses and lens care
products, including the lens case. Eye problems, including corneal ulcers, can
develop rapidly and lead to loss of vision.
• When prescribed for Frequent/Planned Replacement Wear, the need for
strict compliance with the care regimen including cleaning of the lens case,
wearing restrictions, wearing schedule, and follow-up visit schedule should be
emphasized to the patient.
• Studies have shown that contact lens wearers who are smokers have a higher
incidence of adverse reactions than nonsmokers.
Extended Wear
• The risk of microbial keratitis has been shown to be greater among users of
extended wear contact lenses than among users of daily wear contact lenses.
Some researchers believe that these complications are caused by one or
more of the following: a weakening of the cornea’s resistance to infections,
particularly during a closed-eye condition, as a result of hypoxia; an eye
environment which is somewhat more conducive to the growth of bacteria
and other microorganisms, particularly when a regular periodic lens removal
and disinfecting or disposal schedule has not been adhered to by the patient;
improper lens disinfection or cleaning by the patient; contamination of lens
care products; poor personal hygiene by the patient; patient unsuitability to the
particular lens or wearing schedule; accumulation of lens deposits; damage to
the lens; improper fitting; length of wearing time; and the presence of ocular
debris or environmental contaminants.
• While the great majority of patients successfully wear contact lenses, extended
wear of lenses also is reported to be associated with a higher incidence and
degree of epithelial microcycsts and infiltrates, and endothelial polymegathism,
which require consideration of discontinuation or restriction of extended wear.
The epithelial conditions are reversible upon discontinuation of extended wear.
The long term risk of microbial keratitis has not been determined for this lens.
Post-marketing studies are in progress.
The reversibility of endothelial effects of contact lens wear has not been
conclusively established. As a result, practitioners’ views of extended wearing
times vary from not prescribing extended wear at all to prescribing flexible
wearing times from occasional overnight wear to prescribing extended wearing
periods from 1 to 30 days with specified intervals of no lens wear for certain
patients, with follow-up visits, and with proper care regimen.
• If a patient experiences eye discomfort, excessive tearing, vision changes, or
redness of the eye, the patient should be instructed to immediately remove
lenses and promptly contact his or her eye care professional.
PReCAUTIONs
Special Precautions for Eye Care Professionals
• 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
material are not evaluated in significant numbers
Consequently, when selecting an appropriate lens design and parameters,
the eye care professional should consider all characteristics of the lens that
can affect lens performance and ocular health, including oxygen permeability,
wettability, central and peripheral thickness, and optic zone diameter.
The oxygen transmissibility is below the established threshold required to
prevent overnight corneal edema for the extremes of the power range, above
+3.00D and –5.00D. 1 In the U.S. clinical study, the rate of infiltrative keratitis was
found to be higher with higher lens powers (see Clinical Studies section of this
package insert).
• The potential impact of these factors on the patient’s ocular health should be
carefully weighed against the patient’s need for refractive correction; therefore,
the prescribing eye care professional should carefully monitor the continuing
ocular health of the patient and lens performance on eye.
• Eye care professionals should instruct the patient to REMOVE A LENS
IMMEDIATELY if an eye becomes red or irritated.
• Fluorescein, a yellow dye, should not be used while the lenses are on the eyes.
The lenses absorb this dye and become discolored. Whenever fluorescein
is used in eyes, the eyes should be flushed with sterile saline solution that is
recommended for in-eye use.
1 Holden BA, Mertz GW. Critical Oxygen Levels to Avoid Corneal Edema for Daily and Extended
Wear Contact Lenses. Invest Ophthalmol Vis Sci 25:1162, 1984.
• The patient should be instructed to always discard disposable lenses and lenses
worn on a frequent/planned replacement schedule after the recommended
wearing schedule prescribed by the eye care professional.
• Some patients will not be able to tolerate continuous wear even if able to
tolerate the same or another lens on a daily wear basis. Some patients who
are able to tolerate continuous wear will not be able to wear their lenses
continuously for 30 days. Patients should be carefully evaluated for continuous
wear prior to prescription and dispensing, and eye care professionals should
conduct early and frequent follow-up examination to determine ocular
response to continuous wear.
• As with any contact lens, follow-up visits are necessary to assure the
continuing health of the patient’s eyes. The patient should be instructed as to a
recommended follow-up schedule.
• Aphakic patients should not be fitted with Bausch + Lomb PureVision ® 2
(balafilcon A) Visibility Tinted Contact Lenses until the determination is made
that the eye has healed completely.
In Addition, For Therapeutic Use
• Close professional supervision is necessary for therapeutic use of
Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility Tinted Contact Lenses.
• Medications necessary for treatment should be used with caution under close
supervision by the eye care professional.
Eye care professionals should carefully instruct patients about the following lens
care and safety precautions. For therapeutic use, in some circumstances only
the eye care professional will insert and remove lenses and if so, patients should
be instructed NOT to handle lenses themselves. It is strongly recommended
that patients be provided with a copy of the Bausch + Lomb PureVision ® 2
(balafilcon A) Visibility Tinted Contact Lens Patient Information Booklet
available from Bausch + Lomb and understand its contents prior to dispensing
the lenses.
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 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 fingernails.
• Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing
and wearing instructions in the Patient Information Booklet for the Bausch +
Lomb ® PureVision ® 2 (balafilcon A) Visibility Tinted Contact Lens and 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.
• For THERAPEUTIC USE, in some circumstances only the eye care
professional will insert and remove lenses and if so, patients should be instructed
NOT to handle lenses themselves.
Solution Precautions
Do not use the Allergan Ultracare Disinfecting System or any of its
components (Ultracare Disinfecting Solution, Ultracare Neutralizing
Tablets, Lens Plus Daily Cleaner, and Ultrazyme Enzymatic Cleaner) to
clean and disinfect the Bausch + Lomb PureVision ® 2 (balafilcon A) Visibility
Tinted Contact Lens because the lens dimensions will be altered.
Eye injury due to irritation or infection may result from lens contamination. To reduce
the risk of contamination, review the appropriate manufacturer’s labeled lens care
instructions with the patient.
• Always use
fresh unexpired lens care solutions.
• Always follow directions in the package inserts for the use of contact lens
solutions.
• Sterile unpreserved solutions, when used, should be discarded after the time
specified in the labeling directions.
• Always keep the lenses completely immersed in the recommended storage
solution when lenses are not being worn (stored). Prolonged periods of drying
will damage lenses. Follow the lens care directions for Care for a Dried Out
(Dehydrated) Lens in the Patient Information Booklet if lens surface does
become dried out.
• Do not use saliva or anything other than the recommended solution for
lubricating or wetting lenses.
• Tap water, distilled water or homemade saline should not be used as a substitute
for any component in the lens care regimen since they have been associated
with an Acanthamoeba keratitis infection.
• Never use conventional hard contact lens solutions that are not also
recommended for use with prescribed lenses.
• Do not mix or alternate lens care systems or solutions unless indicated in the
lens care system labeling.
• Do not heat the chemical disinfection solution or lenses.
Lens Wearing Precautions
• Never wear lenses beyond the period recommended by the eye care
professional.
• If the lens sticks (stops moving) on the eye, follow the recommended directions
on Care for a Sticking Lens. The lens should move freely on the eye for the
continued health of the eye. If nonmovement of the lens continues, the patient
should be instructed to immediately consult his or her eye care professional.
• Avoid, if possible, all harmful or irritating vapors and fumes while wearing lenses.
• If aerosol products 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 professional.
Topics to Discuss with the Patient
• As with any contact lens, follow-up visits are necessary to assure the continuing
health of the eyes. The patient should be instructed as to a recommended
follow-up schedule.
• Patients should be advised about wearing lenses during sporting and water
related activities. Exposure to water while wearing contact lenses in activities
such as swimming, water skiing and hot tubs may increase the risk of ocular
infection including but not limited to Acanthamoeba keratitis.
• Always contact the eye care professional before using any medicine in the eyes.
Who Should Know That the Patient is Wearing Contact Lenses
• Patients should inform their doctor (health care professional) about being a
contact lens wearer.
• Patients should always inform their employer of being a contact lens wearer.
Some jobs may require the use of eye protection equipment or may require that
you do not wear lenses.
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 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 the patient notices any of the above, he or she should be instructed to
•
Immediately remove the lenses.
• If the discomfort or problem stops, the patient should look closely at the lens. If
the lens is in any way damaged, do not put the lens back on the eye. The patient
should place the lens in the storage case and contact the 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, the patient should thoroughly clean, rinse,
and disinfect the lenses; then reinsert them. After reinsertion, if the problem
continues, the patient should immediately remove the lenses and consult
his or her eye care professional.
If the above symptoms continue after removal of the lens, or upon reinsertion
of a lens, or upon insertion of a new lens, the patient should immediately
remove the lenses and contact his or her eye care professional or
physician, who must determine the need for examination, treatment or referral
without delay. (See Important Treatment Information for Adverse Reactions.)
A serious condition such as infection, corneal ulcer, corneal vascularization, or
iritis may be present, and may progress rapidly. Less serious reactions such as
abrasions, epithelial staining or bacterial conjunctivitis must be managed and
treated carefully to avoid more serious complications.
Important Treatment Information for Adverse Reactions
Sight-threatening ocular complications associated with contact lens wear can
develop rapidly, and therefore early recognition and treatment of problems
are critical. Infectious corneal ulceration is one of the most serious potential
complications, and may be ambiguous in its early stage. Signs and symptoms of
infectious corneal ulceration include discomfort, pain, inflammation, purulent
discharge, sensitivity to light, cells and flare, and corneal infiltrates.
Initial symptoms of a minor abrasion and an early infected ulcer are sometimes
similar. Accordingly, such epithelial defect, if not treated properly, may develop
into an infected ulcer. In order to prevent serious progression of these conditions,
a patient presenting symptoms of abrasions or early ulcers should be evaluated as
a potential medical emergency, treated accordingly, and be referred to a corneal
specialist when appropriate. Standard therapy for corneal abrasions such as eye
patching or the use of steroids or steroid/antibiotic combinations may exacerbate
the condition. If the patient is wearing a contact lens on the affected eye when
examined, the lens should be removed immediately and the lens and lens care
products retained for analysis and culturing.
During THERAPEUTIC USE, an adverse effect may be due to the original
disease or injury or may be due to the effects of wearing a contact lens. There
is a possibility that the existing disease or condition might become worse when
a soft contact lens for therapeutic use is used to treat an already diseased or
damaged eye. The patient should be instructed to avoid serious eye damage by
contacting the eye care professional IMMEDIATELY if there is any increase in
symptoms while wearing the lens.
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