VISIONBLUE

VISIONBLUE is an FDA-registered drug product whose active ingredient is TRYPAN BLUE. It is labelled by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. taken by intraocular and marketed as a human prescription drug product. Identifiers on file: NDC 68803-612, application NDA021670, label effective 20260417. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TRYPAN BLUE are most often described in connection with: aid ophthalmic, surgery staining, anterior capsule, indications usage, visionblue indicated, diagnostic dye. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Indications & Usage VisionBlue® 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens. VisionBlue® 0.06% is a diagnostic dye indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.

Dosage & Administration Cataract surgery. VisionBlue® 0.06% is packaged in a single-patient-use syringe filled to a volume of 0.5 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 aqueous. 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. Inject an air bubble into the anterior chamber; Carefully apply VisionBlue® 0.06% onto the lens capsule; Remove all excess dye from the anterior chamber.

Contraindications 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. Insertion of a non-hydrated (dry-state), hydrophilic acrylic intraocular lens (IOL).

Adverse Reactions 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. Inadvertent staining of the posterior lens capsule and vitreous face. To report SUSPECTED ADVERSE REACTIONS contact, Dutch Ophtalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

What is VISIONBLUE used for?
Indications & Usage VisionBlue® 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens. VisionBlue® 0.06% is a diagnostic dye indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.

Who makes VISIONBLUE?
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. is the labeler of record for VISIONBLUE.

What form does VISIONBLUE come in?
administered by intraocular. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is VISIONBLUE prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has VISIONBLUE been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.