TISSUEBLUE

TISSUEBLUE is an FDA-registered drug product whose active ingredient is BRILLIANT BLUE G. 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 68803-722, application NDA209569, 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 BRILLIANT BLUE G are most often described in connection with: indicated selectively, internal limiting, membrane ilm, indications usage, tissueblue disclosing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Indications & Usage TissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).

Dosage & Administration TissueBlue 0.025% is carefully injected into the Balanced Salt Solution (BSS)-filled vitreous cavity using a blunt cannula attached to the pre-filled syringe, without allowing the cannula to contact the retina or allowing TissueBlue to get under the retina. Sufficient staining is expected within a few seconds. Following staining, all excess dye should be removed from the vitreous cavity. Inject TissueBlue 0.025% directly in a Balanced Salt Solution (BSS)-filled vitreous cavity. Excess TissueBlue should be removed from the vitreous cavity.

Contraindications None None

Adverse Reactions Adverse reactions that have been reported in procedures that included the use of Brilliant Blue G Ophthalmic Solution have often been associated with the surgical procedure. These complications include retinal (retinal break, tear, hemorrhage, and detachment) and cataracts. Adverse reactions that have been reported in procedures that included the use of TissueBlue 0.025% have often been associated with the surgical procedure. The complications include retinal (retinal break, tear, hemorrhage, and detachment and cataracts. To report SUSPECTED ADVERSE REACTIONS, contact Dutch Ophthalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

What is TISSUEBLUE used for?
Indications & Usage TissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).

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

What form does TISSUEBLUE 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 TISSUEBLUE 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 TISSUEBLUE 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.