Bausch & Lomb SofLens Toric Contact Lenses - Manual

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, various 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 each use.
WEArINg SCHEduLE
The wearing and replacement schedules should be determined by the eye care professional.
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 adhering 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
schedule chosen by the eye care professional should be provided to the patient.
Continuous Wear (Greater than 24 hours or while asleep)
The wearing schedule should be determined by the prescribing eye care professional for each
individual patient, based upon a full examination and patient history as well as the eye care
professional’s experience and professional judgment. Bausch & Lomb recommends beginning
extended wear patients with the recommended initial daily wear schedule, followed by a period
of daily wear, and then gradual introduction of extended wear one night at a time, unless
individual considerations indicate otherwise.
The eye care professional should examine the patient in the early stages of extended wear to
determine the corneal response. The lens must be removed, cleaned and disinfected or disposed
of and replaced with a new lens, as determined by the prescribing eye care professional. (See
the factors discussed in the Warnings section.) Once removed, a lens should remain out of
the eye for a period of rest overnight or longer, as determined by the prescribing eye care
professional.
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® Toric (alphafilcon A) 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 potentially 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 disadvantages 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 spectacle 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 provides 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 circumstances.
Then have the patient look at familiar near objects such as a watch face or fingernails. Again
assess the reaction. 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 symptoms 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 particularly 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 monovision 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 SofLens® Toric (alphafilcon A) Visibility
Tinted Contact Lens Patient Information Booklet.
HANdLINg OF LENSES
Patient Lens Care Directions
When lenses are dispensed, the patient should be provided with appropriate and adequate
instructions and warnings for lens care handling. The eye care professional should recommend
appropriate and adequate procedures and products for each individual patient in accordance with
the particular lens wearing schedule and care system selected by the eye care professional, the
specific instructions for such products and the particular characteristics of the patient.
Frequent/Planned Replacement and Disposable Wear
For complete information concerning the care, cleaning and disinfection of contact lenses refer to
the SofLens® Toric (alphafilcon A) 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.
rEPOrTINg OF AdVErSE rEACTIONS
All serious adverse experiences and adverse reactions observed in patients wearing BAUSCH &
LOMB SofLens® Toric (alphafilcon A) 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
1-800-462-1720
HOW SuPPLIEd
Each sterile lens is supplied in a plastic package containing borate buffered saline solution. The
container is marked with the manufacturing lot number of the lens, the base curve, sphere
power, cylinder power, axis, diameter and expiration date.
Bausch & Lomb Incorporated
Rochester, NY 14609
© Bausch & Lomb Incorporated. All rights reserved worldwide. Bausch & Lomb, SofLens,
Lo-Torque, and Formcast are trademarks of Bausch & Lomb Incorporated. Printed in U.S.A.
8002605
SyMBOL rEFErENCE guIdE FOr LABEL 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
Diopter (lens power)
Authorized representative in European community
Caution: Federal (U.S.A.) law restricts this device to
sale by or on the order of a licensed practitioner.
Base curve
Sphere power (diopters)
Visibility Tinted Contact Lenses
PACKAGE INSERT/
FITTING GUIDE
12 13 14 15 16 17
Cylinder axis (degrees)
Cylinder Power (diopters)
18
For Astigmatism For Astigmatism
Toric (alphafilcon A)
Visibility Tinted
Contact Lenses
PACKAgE INSErT/
FITTINg guIdE
CAuTION: Federal (u.S.A.) law restricts this
device to sale by or on the order of a licensed
practitioner.