VisionBlue® 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.

Cataract surgery.

VisionBlue® 0.06% is packaged in a 2.25 mL syringe to which a blunt cannula has to be attached.

After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of VisionBlue® 0.06% by the aqeous. VisionBlue® 0.06% is carefully applied onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule. The anterior chamber is then irrigated with balanced salt solution to remove all excess dye. An anterior capsulotomy can then be performed.

VisionBlue® 0.06% is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.

VisionBlue® 0.06% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye. The dye may be absorbed by the IOL and stain it.

Excessive staining:

It is recommended that after injection all excess VisionBlue® 0.06% is immediately removed from the eye by thorough irrigation of the anterior chamber.

Adverse reactions reported following use of VisionBlue® 0.06% include discoloration of high water content hydrogen intraocular lenses (see contraindications) and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week.

VisionBlue® (trypan blue ophthalmic solution) 0.06% is a sterile solution of trypan blue (an acid di-azo group dye). VisionBlue® 0.06% is a selective tissue staining agent for use as a medical aid in ophthalmic surgery.

Each mL of VisionBlue® 0.06% contains: 0.6 mg trypan blue; 1.9 mg sodium mono-hydrogen orthophosphate (Na 2HPO 4·2H 2O); 0.3 mg sodium di-hydrogen orthophosphate (NaH 2PO 4·2H 2O); 8.2 mg sodium chloride (NaCl); and water for injection. The pH is 7.3 – 7.6. the osmolality is 257-314 mOsm/kg.

The drug substance trypan blue has the chemical name 3,3’-[(3,3’-dimethyl-4,4’-biphenylylene) bis (azo)] bis (5-amino-4-hydroxy-2,7-naphthalenedisulfonic acid) tetra sodium salt, a molecular weight of 960.8, a molecular formula of C 34H 24N 6Na 4O 14S 4, and has the following chemical structure:

VisionBlue® 0.06% is supplied as follows:

0.5 mL of VisionBlue® 0.06% in a sterile single-use Luer Lok, 2.25 mL glass syringe, grey rubber plunger stopper and tip cap with polypropylene plunger rod in a peel pouch. Ten pouched products are packed in on distribution box.

Store between 15-25°C (59-77°F). Protect form direct sunlight.

Patients should be advised that if a non-hydrated, hydrophilic acrylic intraocular lens (IOL) is inserted into their eye, it may absorb the dye and become stained.

Manufactured by

D.O.R.C. International b.v.

Scheijdelveweg 2

3214 VN Zuidland

The Netherlands

Distributed in the United States by

Dutch Ophthalmic, USA

10 Continental Drive, Bldg 1

Exeter, NH 03833, USA

Phone: 800-75-DUTCH of 603-778-6929

US Patents 6,367,480 and 6,720,314

Copyright ©, 2012 Dutch Ophthalmic Research Center