CooperVision Biofinity Disposable Monthly Contact Lenses Instructions

CooperVision Biofinity Disposable Monthly Contact Lenses

LENS FORM AND CHARACTERISTICS

The BIOFINITY and BIOFINITY XR Sphere (comfilcon A), BIOFINITY ENERGYS™ Asphere (comfilcon A), BIOFINITY Toric (comfilcon A), BIOFINITY XR Toric (comfilcon A), BIOFINITY Multifocal (comfilcon A), BIOFINITY XR Multifocal (comfilcon A) and BIOFINITY Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lens is a hemispherical flexible shell that covers the cornea and extends slightly beyond the limbus, covering a portion of the adjacent sclera. In the hydrated state, the lens tends to conform to the curvatures of the anterior eye.

The lens material (comfilcon A), when hydrated, consists of 52% comfilcon A and 48% water by weight when immersed in buffered saline. The material has a refractive index of 1.40 and the lens has a visible light transmittance of > 97%. The oxygen permeability of the material at 35°C is 128 x 10-11 (cm2/sec) (ml O2/ml x mm Hg) determined by the coulometric method.
The hydrophilic properties of the BIOFINITY and BIOFINITY XR Sphere (comfilcon A), BIOFINITY ENERGYS™ Asphere (comfilcon A), BIOFINITY Toric (comfilcon A), BIOFINITY XR Toric (comfilcon A), BIOFINITY Multifocal (comfilcon A), BIOFINITY XR Multifocal (comfilcon A) and BIOFINITY Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lens require that it be maintained in a fully hydrated state in a solution having tonicity compatible with tears. The lens material is stable, has good mechanical strength, and is elastic in its hydrated state. If the lens dries out, it will become hard and appear somewhat warped. If the lens dries out, advise patients to discard the dried- out lens.

LENS PARAMETERS AVAILABLE

BIOFINITY (comfilcon A)

FITTING CONCEPT

The fitting concept is based on the draping effect of a high water content lens. Various base curves are achieved when the peripheral portion of the BIOFINITY and BIOFINITY XR Sphere (comfilcon A), BIOFINITY ENERGYS™ Asphere (comfilcon A), BIOFINITY TORIC (comfilcon A), BIOFINITY XR Toric (comfilcon A), BIOFINITY Multifocal (comfilcon A), BIOFINITY XR Multifocal (comfilcon A) and BIOFINITY Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lens flexes to the curvature of the cornea. The water content of the lens combined with thin lens sections permits excellent draping across a broad range of corneal curvatures. The draping effect of the lens automatically adjusts to the sagittal height for each cornea. The lens parallels the apex of the cornea providing broad apical contact of the central cornea, vaulting or “clearance” of the limbus and light scleral bearing.

PATIENT SELECTION
An examination, including history, refraction, keratometry, biomicroscopy, and other pertinent tests and measurements should be performed. If the patient has the necessary qualifications and no contraindications exist, the patient may be considered for fitting.

ACTIONS
When placed on the cornea in its hydrated state, the BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina. The toric lens provides a more even surface over the uneven astigmatic cornea and thus helps to focus light rays on the retina.

INDICATIONS (USES)
BIOFINITY and BIOFINITY XR SPHERE (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

BIOFINITY ENERGYS™ Asphere (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

BIOFINITY TORIC and BIOFINITY XR TORIC (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non- diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters.

BIOFINITY MULTIFOCAL and BIOFINITY XR MULTIFOCAL (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters with add powers from +0.50 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

BIOFINITY TORIC MULTIFOCAL (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons with non- diseased eyes in powers from -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters.

The BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses may be prescribed for extended wear for up to 6 nights and 7 days of continuous wear. It is recommended that the contact lens wearer be first evaluated on a Daily Wear schedule prior to overnight wear. The lenses may be prescribed for either one-week disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement. When prescribed for frequent replacement, the lenses must be cleaned and disinfected using a chemical disinfection system only.

CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS
Please refer to the Package Insert PI01099.

GENERAL FITTING PROCEDURE

• Perform a preliminary evaluation to determine distance refraction as well as to rule out contraindications to contact lens wear as described in the Package Insert.
• Initial lens power is determined from the patient’s spherical equivalent prescription corrected to the corneal plane. The power of the contact lens prescription is the same as the spectacle Rx when the power is less than 4.00 D in both meridians. When the power is greater than or equal to 4.00 D, vertex the prescription to the spectacle plane. Place the lens on the eye. Allow the lens to remain on the eye long enough to achieve a state of equilibrium. Small variation in the tonicity, pH of the lens solutions and individual tear composition may cause slight changes in fitting characteristics.
• See CLINICAL ASSESSMENT below for general lens fitting criteria.

CLINICAL ASSESSMENT

1. CRITERIA OF A WELL-FITTED LENS
   • Full corneal coverage.
   • Good centration (concentric about the visible iris).
   • Satisfactory lens sag (in up gaze 0.10 to 1.00mm is ideal) with the blink.
   • The lens moves freely when manipulated with digital pressure against the lower lid.
   • Satisfactory comfort response by the patient.
   • Satisfactory vision response by the patient.
2. CHARACTERISTICS OF A TIGHT (STEEP) LENS
   • Good centration.
   • Little or no up gaze sag.
   •  The lens resists movement when manipulated with digital pressure against the lower lid.
   • Good comfort.
   • Vision may be blurred and clear immediately following blink.
   • Bubble(s) under the lens.
   • Conjunctival indentation and/or blanching of limbal vessels at the lens edge.
   • Limbal-conjunctival hyperemia.
3. CHARACTERISTICS OF A LOOSE (FLAT) LENS
   • Decentration (usually temporally and/or superiorly).
   • Excessive up gaze sag.
   • Reduced comfort response-usually lower lid sensation.
   • Lens edge standoff.
   • Unstable vision.

BIOFINITY SPHERE AND ENERGYS LENS FITTING GUIDELINES

• A spherical over-refraction should be performed to determine the final lens power after the lens fit is judged acceptable. The spherical over-refraction should be combined with the trial lens power to determine the final lens prescription. The patient should experience good visual acuity with the correct lens power unless there is excessive residual astigmatism.
• If vision is acceptable, perform a slit lamp examination to assess adequate fit (centration and movement). If fit is acceptable, dispense the lenses instructing the patient to return in one week for assessment.

BIOFINITY TORIC LENS FITTING GUIDELINES
Determine Patient’s Power Requirements:

• Convert the patient’s spectacle Rx to minus cylinder form.
  • The sphere and cylinder power of the contact lens prescription is the same as the spectacle Rx when the power is less than 4.00 D in both meridians. When the power is greater than or equal to 4.00 D, vertex the prescription to the spectacle plane. Use the closest cylinder power equal or lower than the spectacle cylinder power.
• Check lens fit as described above in General Fitting Procedures.
• Determine Lens Cylinder and Axis Orientation:
  • Locate the Orientation Mark: To help determine the proper orientation of the toric lens, you’ll find one mark about 1mm from the lens edge representing the vertical position of the lens at 6 o’clock. You’ll need a biomicroscope and a 1mm or 2mm parallelpiped to highlight the mark when the lens is fitted to the eye. There are a number of techniques that you can use to improve the visibility of the 6 o’clock mark. With your parallelpiped and medium magnification (10x or 15x), slowly pan down the lens, looking just below the direct illumination at the retro illuminated area. Backlighting the mark this way should make it more visible. Sometimes manipulating the lower lid may be necessary to uncover the mark.
  • Observe Lens Rotation and Stability: Observe the position and stability of the 6 o’clock mark. The 6 o’clock mark is not a “must” however; the absolute requirement is that the axis position be stable and repeatable. The mark may stabilize somewhat left or right (drift) of the vertical meridian and still enable you to fit a toric lens for that eye, as long as the lens always returns to the same “drift axis” position after settling. The deviation can be compensated for in the final prescription. Your objective is to ensure that whatever position the initial lens assumes near 6 o’clock, this position must be stable and repeatable. With full eye movement or heavy blink, you may see the marks swing away, but they must return quickly to the original stable position. If the lens does not return quickly, you may need to select a different lens.
  • Assessing Rotation: Imagine the eye as a clock dial and every hour represents a 30° interval. If the orientation mark of the initial lens stabilizes somewhat left or right of the vertical position, the final lens will orient on the eye with the same deviation. You can use an axis reticule in the slit lamp or use a line-scribed lens in a spectacle trial frame to measure or estimate the “rotation” of the cylinder axis. To compensate for this “rotation”, measure or estimate the “rotation”, then add or subtract it from the refractive axis to determine the correct cylinder axis. Use the LARS (Left Add, Right Subtract) method to determine which direction to compensate.
• Determine the final lens power:
  • When the diagnostic lens has its axis aligned in the same meridian as the patient’s refractive axis, a sphero-cylindrical over-refraction may be performed, and visual acuity determined. Adjust the lens power as required. However, when the diagnostic lens axis is different from the patient’s refractive axis, the crossed axes makes sphero-cylindrical over-refraction and computing the resultant power difficult and is not advisable. A spherical over-refraction may be used if warranted by visual acuity.

BIOFINITY MULTIFOCAL LENS FITTING GUIDELINES

Presbyopia Needs Assessment
Multifocal contact lenses may produce compromise to vision under certain circumstances and the patient should understand that they might not find their vision acceptable in specific situations (i.e., reading a menu in a dimly lit restaurant, driving at night in rainy/foggy conditions, etc.). Therefore, caution should be exercised when the patient is wearing the correction for the first time until they are familiar with the vision provided in visually challenging environments. Occupational and environmental visual demands should be considered. If the patient requires critical visual acuity and stereopsis, it should be determined by trial whether this patient can function adequately with the Biofinity Multifocal contact lenses for the correction of presbyopia. Biofinity Multifocal contact lenses for the correction of presbyopia 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 need to ensure they meet state driver’s license requirements and should be advised to not drive with this correction, OR may require that additional over-correction be prescribed.

Biofinity Multifocal contact lenses for the correction of presbyopia are not recommended for patients who have 2.00D or greater of refractive cylinder as this level of uncorrected cylinder may lead to additional visual compromise.

Fitting Procedure

• Start with a new refraction and verification of eye dominance (fogging technique).

• Select the distance prescription based on spherical equivalent corrected for the vertex distance.

• Choose D or N lens design based on needed ADD power. For lower add powers, it is advisable to start with the D lens as this lens is distance-biased. For higher add powers, it is advisable to start with a D lens in the dominant eye and an
  N- lens in the non-dominant eye. Choose the lower ADD power when possible. Do not over minus.

• Check lens fitting as described above in General Fitting Procedures.

• Allow patients to adapt to lenses for a minimum of 15 minutes before assessing vision. If binocular vision is unacceptable, perform a monocular over refraction, using hand-held trial lenses, to determine which eye needs improvement.

• To improve distance vision, add +/-0.25D (up to +/-0.50D) to the eye that needs improvement.

• To improve near vision, add +/-0.25D (up to +/-0.50D) to the eye that needs improvement.

BIOFINITY TORIC MULTIFOCAL LENS FITTING GUIDELINES
Prior to fitting any multifocal lens, consider the recommendations Presbyopia Needs Assessment above.

Fitting Procedure

• First determine the toric lens parameters lens as Biofinity Toric Fitting Guidelines above, correcting for distance vision.
• After the appropriate toric parameters are determined, use the Biofinity Multifocal Fitting Guidelines above to determine the appropriate add powers for the patient.

MONOVISION FITTING GUIDELINES

1. Patient Selection

   • 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 0.75 diopter) in one eye may not be a good candidate for monovision.
     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.

   • 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.

   • Ocular Preference Determination Methods
     Method 1 – Determine which eye is the “sight 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. 
     

   • 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.

   • 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 with 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 and base curve selection described earlier in the guide.
   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 the 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 then graduate to newsprint and finally smaller type sizes.
   After the patient’s performance under the above conditions is completed, tests of visual acuity and reading ability under conditions of moderately dim illumination should be attempted.
   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 adaptation 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 Practitioner in conjunction with the patient after carefully considering the patient’s needs.
     All patients should be supplied with a copy of the Patient Instruction manual.

FITTING SUMMARY

• When lenses are dispensed for vision correction, the wearer must be supplied with an appropriate wearing regimen and must fully understand all lens handling and emergency lens care instructions to prevent lens damage as described in the Package Insert and the Patient Information Booklet.
• Fitting performance and visual response should be confirmed with the prescription lenses prior to dispensing and the management of certain adaptive symptoms should be discussed with the patient prior to dispensing.
• It is normal for the patient to experience mild symptoms such as lens awareness, variable vision, occasional tearing (watery eyes) and slight eye redness during the adaptation period. Although the adaptation period varies for each individual, generally within one week these mild symptoms will disappear. If these symptoms persist, the patient should be instructed to contact their Eye Care Practitioner.
• During the first few weeks of lens wear, patients may report a small amount of secretions on their eyelids, hazy vision on awakening and occasional dryness of the eyes during the day. These symptoms are minor and may be alleviated by using a lubricating/re-wetting solution.

PATIENT MANAGEMENT AND FOLLOW-UP CARE

1. DISPENSING VISIT
   Evaluate patient’s lenses on the eyes for physical fit as described in the preceding discussion. Instruct the patient on the technique for soft lens insertion and removal, as well as all aspects of lens care, including cleaning, disinfection, storage, and handling. Dispense to the patient written instructions on lens care and a copy of the BIOFINITY and BIOFINITY XR Sphere (comfilcon A), BIOFINITY ENERGYS™ Asphere (comfilcon A), BIOFINITY Toric and BIOFINITY XR Toric (comfilcon A), BIOFINITY Multifocal and BIOFINITY XR Multifocal (comfilcon A) and BIOFINITY Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lens Patient Instruction Booklet. Review these instructions carefully with your patient.

2. RECOMMENDED WEARING SCHEDULE
   It is recommended that a contact lens-wearing patient see his or her Eye Care Practitioner twice each year or, if so directed, more frequently. The practitioner should determine the appropriate wearing schedule and replacement schedule, which he or she should provide to the patient.
   Daily wear: Patients tend to over wear the lenses initially. Therefore, practitioners should stress to these patients the importance of adhering to a proper initial daily wearing schedule. The practitioner should determine the appropriate wearing schedule and replacement schedule, which he or she should provide to the patient.
   Extended wear: BIOFINITY and BIOFINITY XR Sphere (comfilcon A), BIOFINITY ENERGYS™ Asphere (comfilcon A), BIOFINITY Toric and BIOFINITY XR Toric (comfilcon A), BIOFINITY Multifocal and BIOFINITY XR Multifocal (comfilcon A) and BIOFINITY Toric Multifocal (comfilcon A) are approved for up to 6 nights and 7 days of continuous wear.

3. FOLLOW-UP CARE
   Follow-up care includes routine periodic progress examinations, management of specific problems, if any, and review of proper lens care and handling. Barring complications, the recommended schedule of follow-up examinations should be:
   Daily Wear

   • One-week post-dispensing.
   • One month after dispensing.
   • Three months after dispensing.
   • Every six months thereafter.

4. PROCEDURES AND INSTRUMENTATION FOR FOLLOW-UP VISITS
   (WITH LENSES ON, PREFERABLY FOR AT LEAST SIX HOURS)

   • Record patient’s symptoms, if any.
   • With lenses in place on the eyes, evaluate fitting performance to assure that CRITERIA OF A WELL-FITTED LENS continue to be satisfied. Examine the lenses closely for surface deposition and/or damage.
   • Check visual acuity and refract over lens.
   • Check for residual astigmatism with the aid of a refractor or loose trial lenses (do not use autorefractor).
   • Biomicroscopy:
   • Examine the conjunctiva and lids.
   • Check for lens edge impingement of the sclera, indentation, or vessel blanching, using low to medium magnification.
   • Check integrity of lens edges.
   • Check for surface deposits, deep scratches or edge nicks.

5. PROCEDURES FOR FOLLOW-UP VISITS
   (WITH LENSES REMOVED)

   • Perform a biomicroscopic examination of the cornea and limbus, both with and without the use of fluorescein; check for edema, injection, vascularization, corneal staining, or any indication of iritis.
   • Measure corneal curvatures with keratometer and compare to original values and mire quality. Any deviations from baseline (pre-fit) should be noted.
   • Check for spectacle blur shortly after lenses are removed. Record all measurable values and any remarkable findings.

If any of the above observations are judged to be abnormal, professional judgment is to be used in alleviating the problem and restoring the eye to optimal conditions. If the criteria for a well-fitted lens are not reached during any follow-up examinations, the patient’s fitting procedure should be repeated. The patient should be refitted, with necessary follow-up examinations also repeated.

CARE OF LENSES
Please refer to the “Lens Care Directions” section of the Package Insert.

PATIENT CARE OF LENSES
Please refer to the Package Insert and the Patient Information Booklets for information pertaining to Cleaning/Disinfecting, Lens Care, and Handling Instructions.

HOW SUPPLIED
Each lens is supplied sterile in a blister containing sterile isotonic buffered saline solution. The blisters are packed in boxes. The following information is provided: the base curve, diameter, dioptric power, manufacturing lot number of the lens and the expiration date of the product. When applicable, the blister is also labeled with the add power, cylinder power and cylinder axis.

REPORTING ADVERSE REACTIONS
All serious adverse experiences and adverse reactions in patients wearing the BIOFINITY and BIOFINITY XR Sphere (comfilcon A), BIOFINITY ENERGYS™ Asphere (comfilcon A), BIOFINITY Toric and BIOFINITY XR Toric (comfilcon A), BIOFINITY Multifocal and BIOFINITY XR Multifocal (comfilcon A) and BIOFINITY Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lens or experienced with the lenses should be reported to:
CooperVision, Inc.
711 North Road
Scottsville, NY 14546
USA
800-341-2020
www.coopervision.com

PACKAGE INSERT
For the BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lens Package Insert, please reference PI01099.

References

• CooperVision | Live Brightly.| Eye Contacts

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