Presentation of MONOBLUE SafR 0.55%

Helps in performing capsulorhexis and other uses in the anterior segment, improves tolerance of trypan blue thanks to purification of the raw material and the addition of mannitol.

ophtalmic-blue-trypan-monoblue-safr

Improves tolerance thanks to its purification

To ensure maximum tolerance, the exclusive Arcadophta purification process guarantees the extraction of toxic components such as toludine – violet, and monoazo, thereby improving tolerance of MonoBlue SafR.

blue trypan purification

Improves tolerance thanks to the addition of mannitol

The addition of mannitol, known for its antioxidant properties, combined with the already-purified trypan blue, enhances the tolerance of MonoBlue SafR.

mannitol-wh

Facilitates capsulorhexis by improving staining

The high percentage of blue >95% in Monoblue SafR enhances its staining power on the capsule, or the tissues of the anterior segment such as Descemet’s membranes, trabeculum, etc.

ultra pure trypan blue

Facilitates capsulorhexis through its dedicated packaging

The use of a long pre-filled syringe and specific plunger guarantees a smooth, controlled injection.

syringes blue trypan
ophtalmic surgery on video gr

Testimony

I use Monoblue SafR dye routinely in at least two indications in my ocular surgery.

First of all, it is essential for me in the techniques of DMEK-type endothelial grafts. Its staining properties help to significantly facilitate the dissection of the endothelial graft, but also its positioning in the injector and its visualisation in the anterior chamber. The manipulations and positioning can thus be done more safely.

In all endothelial graft techniques, it is also essential for facilitating the ablation of the endothelium of the recipient eye. This surgical stage thus becomes atraumatic.

In cataract surgery, I also use Monoblue SafR in all situations where performing capsulorhexis is rendered difficult due to poor visualisation of the anterior chamber and in cases of white or very dark cataracts.

Dr. Pierre Yves Santiago, Ophtalliance, Clinique Sourdille, Nantes, France
santiago-surgeon

General indications

  • Temporary staining of the capsule
  • Temporary staining of intrastromal corneal  tissue
  • Temorary staining of the Descemet’s membrane
  • Visualisation of the position of the corneal graft on recipient tissues during keratoplasty
ophtalmic surgery zone anterior gr

Instruction for use

MONOBLUE SafR: Solution de bleu de Trypan stérile et apyrogène

purified-trypan-blue-Monoblue-SafRComposition :

Purified Trypan blue / Mannitol / isotonic buffered vehicle.

Description :

MONOBLUE SafR is a purified Trypan blue isotonic sterile solution presented in single dose syringe containing 0.75 ml of a 0.055% solution. The syringe is packaged in a pouch.

It is externally sterile to allow its use in the operating theatre. Each box contains 5 syringes.

A set of patient labels is provided to allow traceability. MONOBLUE SafR does not contain Latex, Phtalates or preservatives.

Indications :

Temporary staining of the capsule

Temporary staining of intrastromal corneal tissues

Temporary staining of the Descemet membrane

Visualization of the apposition of the graft onto recipient tissues during keratoplasty

Temporary staining of the aqueous humor

Staining of conjunctival cyst

Temporary staining of trabeculum bleb for per-surgical validation or visualization of the

bleb during a new surgery

Staining of antimetabolites for visualization of treatment area

Residual crystalline masses and posterior plaque temporary staining

Temporary staining of the vitreous body

Temporary staining of the Tenon capsule in the enucleation and prosthesis implantation procedure

Contra indications :

Do not use in pregnant women or with presumption of pregnancy. Do not use in nursing women or infants. Do not use in patients with known hypersensitivity.

Precautions :

The presence of Mannitol in MONOBLUE SafR formulation improves significantly its tolerance.

Nevertheless, the intraocular tissues integrity should be taken in consideration to control the staining of the target tissues and to avoid non expected staining of other tissues.

Use MONOBLUE SafR with caution in presence of hydrophilic acrylic intraocular lenses, the hydrated material having shown potential reversible absorption of the dye.

Thoroughly rinse the excess product with a saline solution immediately after application.

Single use medical device. Re-using the syringe may lead to patient contamination.

Do not re-sterilize. Resterilizing the syringe may lead to product damage and leakage.

The integrity of the device is guaranteed if the packaging is not damaged.

Do not use if the pouch is compromised.

Do not use after the expiration date.

Only use cannula between 20G and 25G.

Verify the good mobility of the plunger before use.

Storage conditions:

Store in the original packaging, at ambient temperature, protected from light, in a clean dry place. Do not refrigerate. Do not freeze.

Instructions for use:

Open the pouch over the sterile operating field or inside the sterile area to withdraw the syringe.

Mount an appropriate cannula.

Mobilize the plunger.

Slowly push the plunger to lay the dye directly on the tissue to be stained.

Manage to point the tip of the cannula away from the macula.

Thoroughly rinse the excess dye with a saline solution.

The left over product must be discarded as any hospital waste.

Method of sterilization:

Autoclave

CE marked since September 15, 2011