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Package insert/ fitting guide, Visibility tinted contact lenses for daily wear – Bausch & Lomb SofLens 59 Contact Lenses User Manual

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and individual tear composition may cause slight
changes in fitting characteristics.

c. Allow any increase in tear flow to subside before

evaluating the lens. The time required will vary with the
individual.

3. Initial Lens Evaluation

a. To determine proper lens parameters observe the lens

relationship to the eye using a slit lamp.

• Movement: The lens should provide discernible

movement with:

– Primary gaze blink

– Upgaze blink

– Upgaze lag

• Centration. The lens should provide full corneal coverage.

b. Lens evaluation allows the contact lens fitter to evalu-

ate the lens/cornea relationship in the same manner
as would be done with any soft lens.

4. Criteria of a Well-Fitted Lens

If the initial lens selection fully covers the cornea, provides
discernible movement after a blink, is comfortable and
provides satisfactory visual performance, it is a well fitted
lens and can be dispensed.

5. Characteristics of a Tight (Steep) Lens

A lens which is much too steep may subjectively and
objectively cause distortion which will vary after a blink.
However, if a lens is only marginally steep, the initial sub-
jective and objective vision and comfort findings may be
quite good. A marginally steep lens may be differentiated
from a properly fitted lens by having the patient gaze
upward. A properly fitted lens will tend to slide downward
approximately 0.5mm while a steep lens will remain

relatively stable in relationship to the cornea, particularly
with the blink.

6. Characteristics of a Loose (Flat) Lens

If the lens is too flat, it will:

– Decenter, especially on post-blink.

– Have a tendency to edge lift inferiorly and sit on the lower

lid, rather than positioning between the sclera and palpe-
bral conjunctiva.

– Have a tendency to be uncomfortable and irritating with

fluctuating vision.

– Have a tendency to drop or lag greater than 2.0mm on

upgaze post-blink.

7. Follow-up Care

a. Follow-up examinations are necessary to ensure contin-

ued successful contact lens wear. From the day of dis-
pensing, the following schedule is a suggested guideline
for follow up.

• 3 or 4 days post-dispensing

• 10 days

• 1 month

• 3 months

• every six months thereafter

At the initial follow-up evaluations the eye care profes-
sional should again reassure the patient that any of the
previously described adaptive symptoms are normal, and
that the adaptation period should be relatively brief.

b. Prior to a follow-up examination, the contact lenses

should be worn for at least 4 continuous hours and the
patient should be asked to identify any problems which
might be occurring related to contact lens wear.

c. With lenses in place on the eyes, evaluate fitting perform-

ance to assure that CRITERIA OF A WELL FITTED LENS
continue to be satisfied. Examine the lenses closely for
surface deposition and/or damage.

d. After the lens removal, instill sodium fluorescein [unless

contraindicated] into the eyes and conduct a thorough
biomicroscopy examination.

1. The presence of vertical corneal striae in the posterior

central cornea and/or corneal neovascularization may
be indicative of excessive corneal edema.

2. The presence of corneal staining and/or limbal-

conjunctival hyperemia can be indicative of an unclean
lens, a reaction to solution preservatives, excessive
lens wear, and/or a poorly fitting lens.

3. Papillary conjunctival changes may be indicative of an

unclean and/or damaged lens.

If any of the above observations are judged abnormal, vari-
ous professional judgments are necessary to alleviate the
problem and restore the eye to optimal conditions. If the
CRITERIA OF A WELL FITTED LENS are not satisfied during
any follow-up examination, the patient should be re-fitted
with a more appropriate lens.

PROFESSIONAL FITTING SETS
Lenses must be discarded after a single use and must not
be used from patient to patient.

WEARING SCHEDULE:
The wearing and replacement schedules should be deter-
mined by the eye care professional. The BAUSCH & LOMB

®

SofLens

®

59 (hilafilcon B) Visibility Tinted Contact Lens is

recommended by BAUSCH & LOMB for 2 week replacement.
Regular checkups, as determined by the eye care professional,
are extremely important.

Daily Wear:
There may be a tendency for the daily wear patient to over
wear the lenses initially. Therefore, the importance of adher-
ing to a proper, initial daily wearing schedule should be
stressed to these patients. The wearing schedule should be
determined by the eye care professional. The wearing sched-
ule chosen by the eye care professional should be provided
to the patient.

MONOVISION FITTING GUIDELINES:

1. Patient Selection

A. Monovision Needs Assessment

For a good prognosis the patient should have adequately
corrected distance and near visual acuity in each eye. The
amblyopic patient or the patient with significant astigmatism
(greater than one [1] diopter) in one eye may not be a good
candidate for monovision with the BAUSCH & LOMB

®

SofLens

®

59 (hilafilcon B) Visibility Tinted Contact Lenses

Contact Lens.

Occupational and environmental visual demands should be
considered. If the patient requires critical vision (visual acuity
and stereopsis) it should be determined by trial whether this
patient can function adequately with monovision.
Monovision contact lens wear may not be optimal for such
activities as:

(1)visually demanding situations such as operating poten-

tially dangerous machinery or performing other potentially
hazardous activities; and

(2)driving automobiles (e.g., driving at night). Patients who

cannot pass their state drivers license requirements with
monovision correction should be advised to not drive
with this correction, OR may require that additional over-
correction be prescribed.

B. Patient Education

All patients do not function equally well with monovision
correction. Patients may not perform as well for certain
tasks with this correction as they have with bifocal reading
glasses. Each patient should understand that monovision, as
well as other presbyopic contact lenses, or other alternative,
can create a vision compromise that may reduce visual acuity
and depth perception for distance and near tasks. During the
fitting process it is necessary for the patient to realize the dis-
advantages as well as the advantages of clear near vision in
straight ahead and upward gaze that monovision contact
lenses provide.

2. Eye Selection

Generally, the non-dominant eye is corrected for near vision.
The following test for eye dominance can be used.

A. Ocular Preference Determination Methods
Method 1 - Determine which eye is the "sighting dominant
eye." Have the patient point to an object at the far end of the
room. Cover one eye. If the patient is still pointing directly at
the object, the eye being used is the dominant (sighting) eye.

Method 2 - Determine which eye will accept the added
power with the least reduction in vision. Place a trial specta-
cle near add lens in front of one eye and then the other while
the distance refractive error correction is in place for both
eyes. Determine whether the patient functions best with the
near add lens over the right or left eye.

B. Refractive Error Method
For anisometropic corrections, it is generally best to fit the
more hyperopic (less myopic) eye for distance and the more
myopic (less hyperopic) eye for near.

C. Visual Demands Method
Consider the patient's occupation during the eye selection
process to determine the critical vision requirements. If a

patient's gaze for near tasks is usually in one direction
correct the eye on that side for near.

Example:

A secretary who places copy to the left side of the desk will
usually function best with the near lens on the left eye.

3. Special Fitting Considerations

Unilateral Lens Correction
There are circumstances where only one contact lens is
required. As an example, an emmetropic patient would only
require a near lens while a bilateral myope may require only
a distance lens.

Example: A presbyopic emmetropic patient who requires a
+1.75 diopter add would have a +1.75 lens on the near eye
and the other eye left without a lens.

A presbyopic patient requiring a +1.50 diopter add who is
-2.50 diopters myopic in the right eye and -1.50 diopters
myopic in the left eye may have the right eye corrected for
distance and the left uncorrected for near.

4. Near Add Determination

Always prescribe the lens power for the near eye that pro-
vides optimal near acuity at the midpoint of the patient's
habitual reading distance. However, when more than one
power provides optimal reading performance, prescribe the
least plus (most minus) of the powers.

5. Trial Lens Fitting

A trial fitting is performed in the office to allow the patient to
experience monovision correction. Lenses are fit according
to the directions in the general fitting guidelines.

Case history and standard clinical evaluation procedure
should be used to determine the prognosis. Determine
which eye is to be corrected for distance and which eye is to

be corrected for near. Next determine the near add. With trial
lenses of the proper power in place observe the reaction to
this mode of correction.

Immediately after the correct power lenses are in place, walk
across the room and have the patient look at you. Assess
the patient's reaction to distance vision under these circum-
stances. Then have the patient look at familiar near objects
such as a watch face or fingernails. Again assess the reac-
tion. As the patient continues to look around room at both
near and distance objects, observe the reactions. Only after
these vision tasks are completed should the patient be asked
to read print. Evaluate the patient’s reaction to large print
(e.g. typewritten copy) at first and than graduate to news
print and finally smaller type sizes.

After the patient’s performance under the above conditions
are completed, tests of visual acuity and reading ability
under conditions of moderately dim illumination should be
attempted.

An initial unfavorable response in the office, while indicative
of a guarded prognosis, should not immediately rule out a
more extensive trial under the usual conditions in which a
patient functions.

6. Adaptation

Visually demanding situations should be avoided during the
initial wearing period. A patient may at first experience some
mild blurred vision, dizziness, headaches, and a feeling of
slight imbalance. You should explain the adaptational symp-
toms to the patient. These symptoms may last for a brief
minute or for several weeks. The longer these symptoms
persist, the poorer the prognosis for successful adaptation.

To help in the adaptation process the patient can be advised
to first use the lenses in a comfortable familiar environment
such as in the home.

Some patients feel that automobile driving performance may
not be optimal during the adaptation process. This is partic-
ularly true when driving at night. Before driving a motor
vehicle, it may be recommended that the patient be a
passenger first to make sure that their vision is satisfactory
for operating an automobile. During the first several weeks
of wear (when adaptation is occurring), it may be advisable
for the patient to only drive during optimal driving conditions.
After adaptation and success with these activities, the patient
should be able to drive under other conditions with caution.

7. Other Suggestions

The success of the monovision technique may be further
improved by having your patient follow the suggestions
below.

– Having a third contact lens (distance power) to use when

critical distance viewing is needed.

– Having a third contact lens (near power) to use when

critical near viewing is needed.

– Having supplemental spectacles to wear over the mono-

vision contact lenses for specific visual tasks may
improve the success of monovision correction. This is
particularly applicable for those patients who cannot meet
state licensing requirements with a monovision correction.

– Make use of proper illumination when carrying out visual

tasks.

Success in fitting monovision can be improved by the
following suggestions.

– Reverse the distance and near eyes if a patient is having

trouble adapting.

– Refine the lens powers if there is trouble with adaptation.

Accurate lens power is critical for presbyopic patients.

– Emphasize the benefits of the clear near vision in straight

ahead and upward gaze with monovision.

*The decision to fit a patient with a monovision correction
is most appropriately left to the eye care professional in
conjunction with the patient after carefully considering the
patient's needs.

*All patients should be supplied with a copy of the
BAUSCH & LOMB

®

SofLens

®

59 (hilafilcon B) Visibility

Tinted Contact Lens Patient Information Booklet.

HANDLING OF LENSES
When lenses are dispensed, the patient should be provided
with appropriate and adequate instructions and warnings for
lens handling. The eye care professional should recommend
appropriate and adequate procedures for each individual
patient in accordance with the particular lens wearing schedule.

For complete information concerning the care, cleaning and
disinfection of contact lenses refer to the BAUSCH & LOMB

®

SofLens

®

59 (hilafilcon B) Visibility Tinted Contact Lens

Patient Information Booklet.

CARE FOR A STICKING (NONMOVING) LENS:
If the lens sticks (stops moving), the patient should be
instructed to use a lubricating or rewetting solution in their
eye. The patient should be instructed to not use plain water,
or anything other than the recommended solutions. The
patient should be instructed to contact the eye care
professional if the lens does not begin to move upon
blinking after several applications of the solution, and to
not attempt to remove the lens except on the advice of the
eye care professional.

CARE FOR A DRIED OUT (DEHYDRATED) LENS:
If a soft, hydrophilic contact lens is exposed to air while off
the eye, it may become dry and brittle and need to be re-
hydrated. If the lens is adhering to a surface, apply the

recommended rinsing solution before handling.
To rehydrate the lens:

• Handle the lens carefully.
• Place the lens in its storage case and soak the lens in a

recommended rinsing and storing solution for at least 1
hour until it returns to a soft state.

• Clean lens first, then disinfect the rehydrated lens using

a recommended lens care system.

• If after soaking, the lens does not become soft, if the

surface remains dry, DO NOT USE THE LENS UNTIL IT
HAS BEEN EXAMINED BY YOUR EYE CARE
PROFESSIONAL.

REPORTING OF ADVERSE REACTIONS:
All serious adverse experiences and adverse reactions observed in
patients wearing BAUSCH & LOMB

®

SofLens

®

59 (hilafilcon B)

Visibility Tinted Contact Lenses or experienced with the lenses
should be reported to:

Bausch & Lomb Incorporated
Rochester, New York 14609

Toll Free Telephone Number
In the Continental U.S., Alaska, Hawaii
1-800-828-9030
In New York State

In Canada

1-800-462-1720

1-888-459-5000

HOW SUPPLIED:
Each sterile (STERILE) lens is supplied in a plastic, blister package
containing a saline solution. The container is marked with the manu-
facturing lot number of the lens (LOT), diopter power (F´v), diameter

and expiration date ( ).

Bausch & Lomb and SofLens are registered trademarks of Bausch & Lomb
Incorporated.
© BAUSCH & LOMB INCORPORATED
Rochester, NY 14609 Printed in U.S.A. 8015600
U.S. Patents 6,347,870; 6,044,966 and 4,997,897 and foreign patents.

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contact
lenses

lentilles
de contact

59

59

PACKAGE INSERT/

FITTING GUIDE

CAUTION:
Federal (USA) Law restricts this device to
sale by or on the order of a licensed
practitioner.

(hilafilcon B)

Visibility Tinted Contact Lenses

for Daily Wear

21