Alcon AquaComfort Plus handleiding
Handleiding
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ADVERSE REACTIONS
Potentially serious complications are usually accompanied by one or
more of the following signs or symptoms:
• Foreign body sensation
• Excessive watering or other unusual eye secretions including mucopurulent
discharge
• Redness of the eyes
• Photophobia (sensitivity to light)
• Burning, stinging, itching or other pain associated with the eyes
• Comfort is less compared to when the lens was first placed on eye
• Poor visual acuity (reduced sharpness of vision)
• Blurred vision, rainbows or halos around objects
• Feeling of dryness
If any of the previous signs or symptoms occur:
• The patient should IMMEDIATELY REMOVE THE LENS(ES). If the
discomfort or problem stops, the patient should discard the lens and
replace it with a new one. IF THE PROBLEM CONTINUES AFTER
INSERTING A NEW LENS, THE PATIENT SHOULD IMMEDIATELY REMOVE
THE LENS(ES) AND CONTACT AN EYE CARE PROFESSIONAL AT ONCE
• Patients should be informed that a serious condition such as corneal ulcer,
infection, corneal vascularization, or iritis may be present and may progress
rapidly. Less serious reactions such as abrasions, infiltrates and bacterial
conjunctivitis must be managed and treated early to avoid more serious
complications. Additionally, contact lens wear may be associated with
ocular changes which require consideration of discontinuation or restriction
of wear. These include but are not limited to local or generalized corneal
edema, epithelial microcysts, epithelial staining, infiltrates,
neovascularization, endothelial polymegathism, tarsal papillary changes,
conjunctival injection or iritis.
ADVERSE REACTION REPORTING
If a patient experiences any serious adverse effects associated with the use of
DAILIES
®
(nelfilcon A) One-Day Contact Lenses, licensed eye care professionals
please notify: Alcon Medical Safety in the USA at 1-800-241-7468.
FITTING
For a detailed description of the fitting techniques, refer to the DAILIES
®
(nelfilcon A) One-Day Contact Lenses Professional Fitting and Information
Guide, copies of which are available free of charge from:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX, USA 76134
1-800-241-5999
REPLACEMENT AND WEAR SCHEDULE
DAILIES
®
(nelfilcon A) One-Day Contact Lenses are intended to be worn once
and then discarded at the end of each wearing period. The patient should be
instructed to start the next wearing period with a fresh new lens.
WEARING SCHEDULE
• Daily Wear (less than 24 hours, while awake)
The maximum daily wearing time should be determined by the eye care
professional based upon the patient’s physiological eye condition because
individual responses to contact lenses vary. There may be a tendency for
patients to overwear the lenses initially. The eye care professional should
stress the importance of adhering to the initial maximum wearing schedule.
Studies have not been conducted to show that DAILIES
®
(nelfilcon A)
One-Day Contact Lenses are safe to wear during sleep, therefore patients
should be advised to remove their lenses while sleeping. Normal daily
wear of lenses assumes a minimum of 6 hours of non-lens wear per 24
hour period. Optimum individual wearing schedule will vary.
CLINICAL DETAILS
• Seasonal Allergy Wearers
A one month subjective trial of contact lens wearers with a history of
seasonal allergic conjunctivitis was conducted during a month of expected
high pollen count in various US cities. Information was collected about
allergy-related symptoms, wear-time and comfort during lens wear. Study
results found that these contact lens wearers experienced fewer days of
burning and redness when wearing FOCUS
®
DAILIES
®
contact lenses as
compared to a new pair of their usual lenses. The effects of allergy
medications that may have been used during the study were not assessed.
• All Day Comfort
A one month study of 188 subjects was conducted for the purpose of
evaluating comfort and wearing time for FOCUS
®
DAILIES
®
soft contact
lenses. End of day comfort was measured using a 0 to 10 scale where 0
was unacceptable and 10 was excellent. Wearing time was also recorded
in hours of wear per day.
Baseline values for end of day comfort and average wearing time with the
subject’s pre-study lenses were 6.9 out of 10 and 13.5 hours, respectively.
Study results found that the average end of day comfort for FOCUS
®
DAILIES
®
contact lenses was 7.8 out of 10 with an average wearing time of 14.3 hours.
The values for FOCUS
®
DAILIES
®
were statistically different compared to the
baseline values collected from the pre-study lenses. As in this study, individual
results may vary.
Reference: Bauman, E. (1997). Daily Disposables Versus Other Soft Lens
Modalities. Optician 214: 33-35, 37.
• DAILIES
®
AquaComfort Plus
®
A one-month study was conducted for the purpose of evaluating the
performance for DAILIES
®
AquaComfort Plus
®
lenses. Subjective
performance measures were evaluated by having the subjects rate these
attributes on a scale from 1 to 10, where 1 was “poor/not at all satisfied”
and 10 was “excellent/completely satisfied,” for both their previous
FOCUS
®
DAILIES
®
lenses as well as DAILIES
®
AquaComfort Plus
®
lenses.
Subjects rated DAILIES
®
AquaComfort Plus
®
contact lenses statistically
better for comfort at insertion compared to their own FOCUS
®
DAILIES
®
/
All Day Comfort lenses. Specifically, average comfort at insertion was 9.0
at baseline with FOCUS
®
DAILIES
®
lenses and was 9.5 at one-month with
DAILIES
®
AquaComfort Plus
®
lenses. Additionally, average overall comfort
was 8.8 at baseline with FOCUS
®
DAILIES
®
and was 9.1 at one-month
with DAILIES
®
AquaComfort Plus
®
, while the average comfort at the end of
the day was 7.8 at baseline with FOCUS® DAILIES
®
lenses and was 8.5 at
one-month with DAILIES
®
AquaComfort Plus
®
lenses (changes not
statistically significant).
EMERGENCY LENS CARE
Cleaning and disinfection of the lens is not recommended. The patient should
be reminded to have replacement lenses or back-up spectacles available at all
times.
CARE FOR A STICKING OR TORN LENS
If the lens sticks (stops moving) or cannot be removed from the eye, instruct
the patient to apply 1 to 2 drops of a recommended lubricating or rewetting
solution in accordance with the manufacturer’s instruction for use package
labeling. The patient should blink forcefully several times, then while looking
up slide the lens down onto the white part of the eye and remove the lens by
pinching it between the thumb and forefinger. If the lens continues to stick,
the patient should immediately consult the eye care professional.
If the lens tears in your eye it will feel uncomfortable. Advise patients it is not
possible to lose a contact lens or part of a contact lens behind the eye and that
they should calmly remove the pieces by carefully pinching them as they
would do for normal lens removal. If the lens pieces do not seem to remove
easily the eye may be rinsed with sterile saline. Excessive pinching should be
avoided. If rinsing with saline does not help, instruct patients to contact the
eye care professional for assistance. Lenses can be easily located by the eye
care professional using fluorescein.
EMERGENCIES
Patients should be informed that if chemicals of any kind (household products,
gardening solutions, laboratory chemicals, etc.) are splashed into the eyes, the
patient should: Flush eyes immediately with tap water or fresh saline
solution, remove and discard the lens, and immediately contact the eye
care professional or visit a hospital emergency room without delay.
Additional information regarding emergency treatment may be provided on the
product container label.
HOW SUPPLIED
DAILIES
®
(nelfilcon A) One-Day Contact Lenses are packaged in strips of five
foil sealed blister packs containing phosphate-acetate buffered saline solution
and are steam sterilized . Five blister pack containers are attached
to form a single strip. The package storage saline may contain up to 0.05%
Poloxamer. In addition, the package storage saline for DAILIES
®
AquaComfort
Plus
®
, DAILIES
®
AquaComfort Plus
®
Toric and DAILIES
®
AquaComfort Plus
®
Multifocal One-Day Contact Lenses contains polyethylene glycol (PEG) and
hydroxypropyl methylcellulose (HPMC). The package is marked with the base
curve, diameter, dioptric power, manufacturing lot number and expiration date.
The following may appear on the labels or cartons:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX
76134-2099, USA
© 2013 Novartis
1
Check for actual product availability as additional powers may be introduced over time.
2
New England Journal of Medicine, September 21, 1989; 321 (12), pp.773-783.
Do Not Reuse
DIA
BC
PWR
LO
MED
HI
en
Description
CAUTION: Federal (United States) law restricts this device to
sale by or on the order of a licensed eye care professional.
Steam sterilized
Use by date (Expiry date)
Batch code
Example of two letter language code (English)
Do Not Reuse
Diameter
Base curve
Lens power
“Low” near ADD
“Medium” near ADD
“High” near ADD
European conformity sign
See product instructions
Authorized Representative European Community
Manufacturer
Packaging waste license sign
Symbols/Signs
EXP
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Productinformatie
| Merk | Alcon |
| Model | AquaComfort Plus |
| Categorie | Niet gecategoriseerd |
| Taal | Nederlands |
| Grootte | 4631 MB |
Caratteristiche Prodotto
| Materiaal | Nelfilcon A |
| Aantal per verpakking | 90 stuk(s) |
| Type product | Dagelijks |
| Ultraviolet ( UV) bescherming | Nee |
| Lens diameter | 14 mm |