Alcon Systane Ultra UD Lubricant Eye Drops

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Commercializzato da:

ALCON PTE LTD

Classe:

Class B medical device

Prodotto da:

Alcon Laboratories, Inc.

Area terapeutica:

Ophthalmology

Indicazioni terapeutiche:

For the temporary relief of burning and irritation due to dryness of the eye.

Dettagli prodotto:

Device System Info:[Sterile Medical Device], Sterile Medical Device; Models: Systane® Ultra UD Lubricant Eye Drops - 30 vials, Systane® Ultra UD Lubricant Eye Drops - 5 vials

Data dell'autorizzazione:

2011-11-21

Foglio illustrativo

(PRESERVATIVE-FREE)
INSTRUCTIONS FOR USE
This Instructions For Use (IFU) leaflet contains important product use
and safety information.
Please read carefully and keep this for future use
PRODUCT NAME:
SYSTANE
TM ULTRA UD LUBRICANT EYE DROPS
DESCRIPTION:
SYSTANE
TM
ULTRA UD Lubricant Eye Drops is a sterile, preservative-free solution
containing
polyethylene glycol 400, propylene glycol, hydroxypropyl guar,
sorbitol, aminomethylpropanol, boric
acid, potassium chloride, sodium chloride, and purified water. May
contain hydrochloric acid and/or
sodium hydroxide to adjust pH.
CLINICAL BENEFITS:
When used as directed, SYSTANE
TM
ULTRA UD Lubricant Eye Drops:
•
Provides eye surface protection.
•
Provides dry eye symptom relief and improved visual performance.
•
Provides temporary relief from dryness related to contact lens wear
(before and after contact
lens wear).
•
Moistens your contact lenses, reduces discomfort with contact lens
wear, and helps to remove
particulate material that may cause irritation and/or discomfort.
•
Provides contact lens moisture/rewetting.
INDICATION (USES):
SYSTANE
TM
ULTRA UD Lubricant Eye Drops is indicated for the temporary relief of
burning and
irritation due to dryness of the eye.
SYSTANE
TM
ULTRA UD Lubricant Eye Drops may be used to lubricate and rewet daily,
extended
wear and disposable silicone hydrogel and soft (hydrophilic) contact
lenses. SYSTANE
TM
ULTRA
UD Lubricant Eye Drops moistens your contact lenses, reduces
discomfort with contact lens wear,
and helps to remove particulate material that may cause irritation
and/or discomfort.
INTENDED PURPOSE/USE AND INTENDED USERS:
SYSTANE
TM
ULTRA UD Lubricant Eye Drops is intended for use by consumers for the
temporary
relief of dry eye symptoms.
SYSTANE
TM
ULTRA UD Lubricant Eye Drops is also intended for consumers to
lubricate and
rewet silicone hydrogel and soft (hydrophilic) contact lenses.
PERFORMANCE CHARACTERISTICS:
Based on the total body of evidence from clinical investigations,
published clinical literature and
market