Bausch-lomb SofLens Toric Contact Lenses User Manual download pdf

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ngernails.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

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)

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.

1 2 3 4 5 6 7 8

Summary of Contents

Page 1 - For Astigmatism

1. The presence of vertical corneal striae in the posterior central cornea and/or corneal neovascularization may be indicative of excessive corn

Page 2 - 1 2 3 4 5 6 7 8 9 10 11

TABLE OF CONTENTS PAGEIntroduction 2Description 2Lens Parameters Available 3How the Lens Works (Actions) 4 Indications 4Contraindications

Page 3

TABLE OF CONTENTS PAgEIntroduction 2Description 2Lens Parameters Available 3How the Lens Works (Actions) 4 Indications 4Contraindications

Page 4

TABLE OF CONTENTS PAgEIntroduction 2Description 2Lens Parameters Available 3How the Lens Works (Actions) 4 Indications 4Contraindications

Page 5

TABLE OF CONTENTS PAgEIntroduction 2Description 2Lens Parameters Available 3How the Lens Works (Actions) 4 Indications 4Contraindications

Page 6

1. The presence of vertical corneal striae in the posterior central cornea and/or corneal neovascularization may be indicative of excessive corn

Page 7

1. The presence of vertical corneal striae in the posterior central cornea and/or corneal neovascularization may be indicative of excessive corn

Page 8

1. The presence of vertical corneal striae in the posterior central cornea and/or corneal neovascularization may be indicative of excessive corn

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Bausch-lomb SofLens Toric Contact Lenses User Manual

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Summary of Contents

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