AquaOptic multifunctional contact lens care solution according to TS 21.20.23‑008‑64260974‑2017
No. РЗН 2018/7027 dated 11.04.2018
AquaOptic multifunctional contact lens care solution (hereinafter referred to as the solution) is a transparent or slightly opalescent colorless solution.
Composition per 1 mL: boric acid – 11.0 mg, sodium chloride – 3.0 mg, dinatrium tetraborate decahydrate (borax) – 1.15 mg, trehalose – 0.2 mg, dinatrium edetate dihydrate – 0.2 mg, sodium hyaluronate – 0.1 mg, polyhexamethylenebiguanide hydrochloride (20% solution) – 0.005 mg, poloxamer 407 – 0.03 mg, succinic acid – 0.03 mg, water for injection – up to 1 mL.
The scope is ophthalmology (by prescription).
The solution is intended for daily care of all types of contact lenses and provides cleansing, removal of protein deposits, rinsing, disinfection, storage of contact lenses for long-term comfortable wear.
The solution is suitable for particularly sensitive eyes.
Thanks to a special hydrating complex containing a natural ingredient, sodium hyaluronate (hyaluronic acid), the AquaOptic solution provides soft gliding of the lens on the corneal surface, long-term optimal wetting and comfort. Sodium hyaluronate is a physiological polysaccharide compound contained in both eye tissues and other tissues and fluids of the human body. A special physical and chemical property of sodium hyaluronate molecules is their pronounced ability to bind water molecules. When using the AquaOptic solution, a thin film is formed on the lens surface to protect the eyes from dryness and irritation. The action of the protective film begins almost immediately, thus protecting the eyes from dryness for a long time.
Effective cleaner poloxamer 407 binds protein deposits, preventing their formation on the lenses.
Poly-hexamethylene-biguanide hydrochloride included in the AquaOptic solution has a disinfecting effect, protecting eyes and contact lenses from pathogenic microflora.
Succinic acid has a pronounced antihypoxic and antioxidant effect, in the AquaOptic solution succinic acid reduces the risk of hypoxic complications associated with contact lens wear.
Trehalose is a naturally occurring substance found in a wide variety of organisms. The peculiarity of trehalose lies in its ability to play a protective role with respect to cell membranes in the anhydrobiotic mechanism of plants and microorganisms (a state of slow metabolism that allows them to survive under conditions of dehydration). Due to its physical and chemical characteristics, trehalose complements the wetting, antioxidant and protective properties of the solution.
Daily cleansing, removal of protein deposits, rinsing, disinfection, storage of contact lenses.
No data.
Hypersensitivity to the solution ingredients.
Fill the lens storage container with a fresh AquaOptic solution. Remove the lens from the eye, put it on the palm of your hand and moisten it with a few drops of solution. Gently wipe the lens with your index finger.
Rinse both surfaces of the lens thoroughly with a fresh solution. Place the lens in the appropriate cell of the container. Add a fresh AquaOptic solution to the cell. The lens should be completely immersed in the solution. Close the container cell with the lid. Repeat the same operation with the second lens. Leave the lenses in the closed container overnight or for at least four hours (during this time the lenses are completely cleaned). Before putting on the lenses, rinse them thoroughly with the solution to complete the cleansing process. Pour the solution out of the container and rinse with a fresh solution. Do not cover the container with lids, allow it to dry. After that, close it. The container will be ready for use again.
If you feel dryness, discomfort in the eyes, it is recommended to remove the lens, drop 1-2 drops of AquaOptic solution on its surface and put it back on. You can instill the solution without removing the lenses – 1-2 drops directly into the eyes, then carefully close and open the eyes again, while the lenses are wetted.
To wet the eyes, it is also recommended to use ophthalmic rewetting solutions based on hyaluronic acid without preservatives (for example, Gylan Comfort or Gylan Ultra Comfort).
If the discomfort persists, remove the contact lenses and consult an eye care professional.
Possible allergic reactions.
Use of any eye medicinal products simultaneously with the solution is allowed only under the supervision of an eye care professional.
It does not affect the ability to drive vehicles and work with mechanisms if the solution is used correctly and if the rules for lens care recommended by the physician are followed.
It does not belong to the products that can affect psychomotor state of a person.
By 60, 120, 250 or 450 mL in a plastic bottle with a dispenser and a cap.
1 bottle together with a instruction for use and a lens container or without a lens container in a carton. It is allowed to enclose a lens container in a bag or without a bag in the carton.
Do not use if the package is damaged.
Refer to the instruction for use.
Sterilization using aseptic processing methods.
Store at +2°С to +30°С.
Keep out of reach of children.
2 years.
After opening the bottle – 6 months.
Do not use after expiration date!
By all types of covered vehicles in accordance with the haulage rules, operating on each type of vehicle, at +2°C to +30°C. Keep away from heat.
Grotex LLC, Russia
195279, St. Petersburg, Industrialniy Ave., 71, building 2, lit. A
Tel.: +7 812 385 47 87
Fax: +7 812 385 47 88
AquaOptic multifunctional contact lens care solution is manufactured according to TS 21.20.23-008-64260974-2017 in compliance with international and national standards. The primary packaging of the product and the lens container comply with ISO 9001, ISO 13485.
In terms of biological safety, the product meets the requirements of GOST ISO 10993-1. The medical device is non-toxic. The solution is sterile. The solution is poured under aseptic conditions into sterile bottles in accordance with GOST R ISO 13408-1. The solution osmolality should be 200–400 mOsm/kg, pH – 6.5–7.8, viscosity – 1–3 mPa∙s. The product should keep performance efficiency at temperature from +32°C to +42°C in accordance with GOST R 50444.
Weight of the product in the primary packaging*, (±10%):
It is recommended to use the product individually.
This medical device is intended for independent use at home, as well as for use in medical and preventive institutions.
This product has been designed, manufactured, tested and packaged in compliance with all relevant requirements.
The manufacturer guarantees the medical device quality until the expiration date, provided that the packaging remains intact and the storage conditions are observed.
It is allowed to dispose of the product (including unused solution) in accordance with SanPiN 2.1.7.2790 as class A waste (epidemiologically non-hazardous waste with the composition close to solid municipal waste).
