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VisiSil
Purified Silicone Oil
Tamponade to treat complex retinal detachments
NOT AVAILABLE FOR SALE IN THE U.S. 
- Quality proven product
- Less tissue impregnation
- Reduced emulsification due to high degree of purity & low
level of reactive –OH
end groups
- Subject to all physical & chemical analysis to ensure purity
(H-NMR spectral test, gel permeation
chromatography study & gas chromatography)
- Low level of catalyst impurities
minimizes the risks of interactions with the ocular environment
- Purity beyond comparison
| DESCRIPTION |
VisiSil
is a fractionated, purified, sterile and apyrogenic silicone oil
designed for prolonged tamponade after surgical treatment for severe
retinal detachment. |
| SUPPLY |
10ml
vial in a sterile pouch. |
| INDICATIONS |
Retinal
detachment with giant tear, retinal detachment with proliferative
vitreo retinopathy (PVR), proliferative diabetic retinopathy (PDR)
and traumatic retinal detachment. |
| CONTRAINDICATIONS |
Pseudophakic
patients with silicone intraocular lens (silicone oil can chemically
interact and opacify silicone elastomers). |
| PRECAUTIONS |
As
with any surgical procedure, posterior segment surgery using VisiSil
presents risks which the surgeon must evaluate.
- Single use product
only.
- Do not use if sterile packaging is damaged.
- Do not use after expiration
date.
- Do not resterilize.
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| ADVERSE
REACTIONS |
The
most common adverse reactions include cataract, anterior chamber
oil migration, keratopathy and glaucoma. Other adverse reactions
include optic nerve atrophy, rubeosis iritis, temporary IOP increase,
macular pucker, vitreous hemorrhage, phthisis, traction detachment,
angle block, sub retinal strands, retinal rupture, endophthalmitis,
sub retinal silicone oil, choroidal detachment, aniridia and cystoid
macular edema. Opacification of silicone IOL has been reported
(in vitro). |
| CHARACTERISTICS |
Viscosity (at 25°C):
1000 cs
Refractive index (at 27°C): 1.4002
Specific Gravity (at 27°C): 0.9740
Average Molecular Weight (Daltons): 44,000 ±1000
Poly Dispersion Index: 2.5
Toxic Residue: Nil
Content of –OH end groups: <70 ppm |
| DIRECTIONS |
In aseptic conditions, decant
the contents of the bottle into a sterile syringe. Place the syringe
in a syringe driver in order to facilitate the injection. Plug the
infusion terminal to the tip of the syringe. Inject slowly. During
withdrawal, avoid leaving silicone bubbles in the vitreo-retinal
cavity. Once VisiSil is removed from the patient’s eye, it
should be treated as any human biological product. |
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