australia

MICROGAS – MICROC2F6 and MICROC3F8
Patient Information leaflet

This leaflet is related to the following products, manufactured by Micromed srl
– MicroC2F6 pure – MMD-785 (Hexafluoride
– MicroC2F6 mixed at 16% – MMD-784
– MicroC3F8 pure – MMD-788
– MicroC3F8 mixed at 12% – MMD-787

All these products are implantable medical device, used in ophthalmologic surgery to replace humour vitreous.

The intended purpose of the device

Microgases are inert, high molecular weight gases used to replace vitreous humor during vitrectomy procedures, ab externo surgery, and pneumatic retinopexy. They are injected into the vitreous chamber in order to replace the vitreous and promote retinal adhesion.
The residence time in the eye variable from 4 to 8 weeks. During this period, the gas is gradually replaced by aqueous humor and finally exhaled.

Undesirable side effects:
As with all vitrectomy, ab-externo, or retinopexy surgery, there could be some post-operative complications:
– Neovascular glaucoma;
– Cataract;
– Lenticular opacity;
– Keratopathies;
– Hypertone (increased ocular pressure);
– Transient or permanent decrease in ocular pressure with an evolution towards bulbar tysis;
– Alterations of the macula;
– Detachment of the choroid;
– Retinal tear and/or relapsed retinal detachment.
A notice that any serious incident that occurs in relation to the Microgas should be reported to the Micromed srl (incidenti-e-reclami@micromed.it) and to the Therapeutic Goods Administration on the website https://www.tga.gov.au

Contraindications:
The patients must be careful to anesthesia with nitrous oxide, after the surgery also.
The surgeon must stop the inhalation of the anesthetic at least 15 minutes before the use of the products.

Interaction:
There is no interaction between Microgas and external influences. The patients must be careful to change in pressure and temperature, to avoid hypertone.

Warnings/Precautions:
This page is not intended to replace medical advice.
You have had eye surgery and have been injected with an expandable gas.

Follow the advice and precautions given to you at the hospital. Never stop treatment unless your surgeon tells you to; it helps the operated eye heal better and prevents complications.

Keep your head in the position indicated by your doctor.

Do not rub the operated eye at all. Avoid applying any pressure to the eye, such as while instilling medical eye drops or washing your face.

To avoid a surge in eye pressure:
– Avoid overexertion, such as lifting weights.
– Do not travel by air
– Do not dive at shallow depths
– Do not travel in the mountains at high altitudes
– Avoid any excessive temperature changes, such as getting into an overheated car in the summer.

Have all periodic checkups scheduled by your doctor. Even after healing, your eye should be checked periodically by your eye doctor.

Failure to properly care for it, make dressings and do postoperative checkups can jeopardize the success of your surgery.

Always carry the implant card you were given and show it to the medical staff when you go to the hospital. If you have been under general anesthesia, for whatever reason, the presence of a gas bubble in your eye should be reported to the anesthesiologist.

See your doctor immediately if you experience any symptoms other than those described by your doctor.