Bausch & Lomb SofLens 59 Contact Lenses - Manual (Page 5)

IMPORTANT:
This package insert has been developed to provide practi-
tioners with information covering characteristics of the
BAUSCH & LOMB
® SofLens ® 59 (hilafilcon B) Visibility
Tinted Contact Lens and to illustrate fitting procedures. It is
effective as of April 2003 and supersedes all prior fitting
guides for the product described. Please read carefully and
keep this information for future use.
This package insert 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.
DESCRIPTION:
The BAUSCH & LOMB
® SofLens ® 59 (hilafilcon B) Visibility
Tinted Contact Lens is a soft hydrophilic contact lens which
is available as a spherical lens. The lens is made from the
hilafilcon B material, a hydrophilic copolymer of 2-hydrox-
yethyl methacrylate and N-vinyl pyrrolidone, and is 59%
water by weight when immersed in a sterile saline solution.
This lens is tinted blue with Reactive Blue Dye 246.
The physical / optical properties of the lens are:
Specific Gravity: 1.119
Refractive Index: 1.4036
Light Transmittance: C.I.E. Y value – greater than 95 %
Water Content: 59%
Oxygen Permeability (Dk): 22 x10 -11 [cm 3 O
2
(STP) x cm]/
(sec x cm 2 x mmHg)@35°C
(Polarographic Method)
LENS PARAMETERS AVAILABLE
The BAUSCH & LOMB
® SofLens ® 59 (hilafilcon B) Visibility
Tinted Contact Lens is a hemispherical shell of the following
dimensions:
• Diameter (fT): 14.2mm
• Center Thickness (tc): 0.05mm to 0.75mm
• Base Curve: 8.6mm
• Powers - Spherical (F´v): -0.50D to -6.00D in .25D steps
-6.50D to -9.00D in .50D steps
+0.50D to +6.00D in .25D steps
HOW THE LENS WORKS (ACTIONS):
In its hydrated state, the BAUSCH & LOMB
® SofLens ® 59
(hilafilcon B) Visibility Tinted Contact Lens when placed on
the cornea acts as a refracting medium to focus light rays
on the retina.
INDICATIONS
The BAUSCH & LOMB
® SofLens ® 59 (hilafilcon B) Visibility
Tinted Contact Lens is indicated for the daily wear correction
of refractive ametropia (myopia and hyperopia) in aphakic
and/or not-aphakic persons with non-diseased eyes. The
lens may be prescribed in spherical powers ranging from
+20.00D to -20.00D.
Replacement schedules may vary from patient to patient,
and should be decided by eye care professionals in consul-
tation with their patients. The 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.
CONTRAINDICATIONS (REASONS NOT TO USE):
DO NOT USE the BAUSCH & LOMB
® SofLens ® 59 (hilafilcon
B) Visibility Tinted Contact Lens when any of the following
conditions exist:
• Acute and subacute inflammation or infection of the ante-
rior 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 exag-
gerated by wearing contact lenses
• Allergic reactions of ocular surfaces or adnexa (surround-
ing tissue) that may be induced or exaggerated by wear-
ing 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
® SofLens ® 59 (hilafilcon B) 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 could result in serious
injury to the eye. It is essential that patients follow their
eye care professional’s direction and all labeling instruc-
tions 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.
• Daily wear lenses are not indicated for overnight wear,
and patients should be instructed not to wear lenses
while sleeping. Clinical studies have shown that the risk
of serious adverse reactions is increased when daily wear
lenses are worn overnight.
• 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.
• 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 con
figurations, 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 perform-
ance 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 should be carefully weighed against the patient's
need for refractive correction; therefore, the prescribing
eye care professional should carefully monitor the contin-
uing ocular health of the patient and lens performance on
eye.
• Patients who wear aspheric contact lenses, such as the
BAUSCH & LOMB ® SofLens ® 59, to correct presbyopia
may not achieve the best corrected visual acuity for either
far or near vision. Visual requirements vary with the
individual and should be considered when selecting the
most appropriate type of lens for each patient.
• 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.
• The patient should be instructed to always discard dispos
able lenses and lenses worn on a frequent/planned
replacement schedule after the recommended wearing
schedule prescribed by the eye care professional.
• 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 ® SofLens ® 59 Contact Lenses until the determina-
tion is made that the eye has healed completely.
Eye care professionals should carefully instruct patients
about the following lens care and safety precautions. It is
strongly recommended that patients be provided with a copy
of the SofLens
® 59 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 SofLens® 59
Contact Lenses 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.
Solution Precautions:
• 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 dis
carded 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 use chemical disinfection solutions with heat
unless specifically indicated on product labeling for use in
both heat and chemical disinfection.
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, exer-
cise 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 swim-
ming, 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 practitioner)
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, 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 the eye care professional. If the lens has
dirt, an eyelash, or other foreign body on it, or the prob-
lem 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 the eye care professional.
If the above symptoms continue after removal of the lens, or
upon insertion of a new lens, the patient should immediately
remove the lenses and contact his or her eye care profes-
sional or physician, who must determine the need for exam-
ination, treatment or referral without delay. (See Important
Treatment Information for Adverse Reactions.) A serious
condition such as infection, corneal ulcer, corneal vasculari-
zation, or iritis may be present, and may progress rapidly.
Less serious reactions such as abrasions, epithelial stinging
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 com-
plications, 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 emer-
gency, treated accordingly, and be referred to a corneal spe-
cialist when appropriate. Standard therapy for corneal abra-
sions 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.
SELECTION OF PATIENTS:
The eye care professional should not fit patients who cannot
or will not adhere to a recommended care or replacement
regimen, or are unable to place and remove the lenses
should not be provided with them. Failure to follow handling
and cleaning instructions could lead to serious eye
infections which might result in corneal ulcers.
Patient communication is vital because it relates not only to
patient selection but also to ensure compliance. It is also
necessary to discuss the information contained in the
Patient Information Booklet with the patient at the time of
the initial examination.
Patients selected to wear SofLens® 59 Contact Lenses
should be chosen for their motivation to wear contact lenses,
general health and cooperation. The eye care professional
must take care in selecting, examining and instructing con-
tact lens patients. Patient hygiene and willingness to follow
practitioner instructions are essential to their success.
A detailed history is crucial to determining patient needs and
expectations. Your patient should be questioned regarding
vocation, desired lens wearing time (full or part time), and
desired lens usage (reading, recreation or
hobbies).
Initial evaluation of the trial lens should be preceded by a
complete eye examination, including visual acuity with and
without correction at both distance and near, keratometry
and slit lamp examination.
It is normal for the patient to experience mild symptoms
such as lens awareness, variable vision, occasional tearing
(watery eyes) and slight redness during the adaptation period.
Although the adaptation period varies for each individual,
generally within one week these symptoms will disappear. If
these symptoms persist, the patient should be instructed to
contact his or her eye care professional.
FITTING PROCEDURE:
1. 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 (consider patient hygiene and
mental and physical state),
• make ocular measurements for initial contact lens para-
meter selection, and
• collect and record baseline clinical information to which
post-fitting examination results can be compared.
A prefitting examination should include spherocylinder
refraction and VA, keratometry, and biomicroscopic
examination.
2. Initial Lens Power Selection
a. Lens power is determined from the patient’s spherical
equivalent prescription corrected to the corneal plane.
b. Select the appropriate power lens and place the lens on
the eye. Allow the lens to remain on the eye long enough
(10 to 20 minutes) to achieve a state of equilibrium.
Small variations in the tonicity, pH of the lens solutions,
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