sil 1000 | 2000 | 5000

ophthafutur silicone oils offer a variety of viscosities.

 

High patient and product safety

Multi-step proven and tested ultra-purification process

Safe, biocompatible, sterile, endotoxin-free products

3 years shelf life

ophthafutur sil 1000 2000 5000 packshot

 

THE ISSUE

manufacturing-related impurities

manufacturing-related impurities issue

risks of silicone oil endo­tamponades

With silicone oils, as with all polymers, the characteristics are determined by chain length and chain length distribution.

Risks originate from volatile and short-chained components which are generated during production. These components can penetrate into tissue and damage cells.

Due to the combination of hydrophobicity and polarity, silicone oils can act as a trap for many impurities that can destabilize the tamponade (“emulsification”), even in low concentrations.

OUR ANSWER

multi-step ultra-purification process

multi-step ultra-purification

our response: ultra-purified silicon liquids

ophthafutur® silicone oils are ultra-­purified according to a multi-step FDA approved process, which is ­succesfully performed since 1998.
By combining extraction, thermal treatment and filtration, all critical impurities are separated.

The materials of the primary containers are selected to prevent any ­recontamination during manufac­turing and storage.

purified sil

purity criteria for silicone oils

In addition to the well-established GC-MS methods, the control of the removal of short-chained compounds by gel permeation chromatography (SEC) is an ophthafutur® standard.

usability

intended use

Silicone oils are used as ocular endo­tamponades in cases of severe re­tinal detachment, e.g. solid proliferative vitreo-retinopathy, traumatic detachment and giant tears, as well as other detachments of the retina, which cannot be treated with other forms of therapy.

ophthafutur sil wrong handling ophthafutur sil handling

Silicone oil can be injected into the eye with the support of vitrectomy machines. An adapter kit of the ophthafutur® line will support the oil injection.

Silicone oils exhibit a density < 1 g/cm3. For this reason the oil will float on water.

The eye should be completely filled with silicone oil to avoid cavities which may still contain water or gas.

To avoid high intraocular pressure, the patient should be monitored postoperatively. Due to the lower density, an iri­dectomy at 6 o’clock should be considered.

Emulsifications are one of the known side effects of oil injections and can be triggered by various reasons.

In addition to the precondition of the patient, the quality of the injected oil may play a role. The likelihood of emulsifications can be reduced by using ultrapurified oil.

ophthafutur sil luer lock

The standard glass syringe, which is widely used in ophthalmology has a plastic luer lock at the tip. For added protection of the luerlock and safer handling, a mechanical support tube is shrunk over the tip.

 

For additional information please consult directions for use.

 

For additional information please consult directions for use.