Ophthalmic Dye — Capsule Staining (Cataract Surgery) Pregnancy: Risk Summary There are no available data on the use of VisionBlue® 0.06% in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic absorption of VisionBlue® 0.06% in humans is expected to be negligible following injection and subsequent removal of the drug at the completion of surgical procedures. Adequate animal reproduction studies were not conducted with VisionBlue® 0.06%, however, trypan blue has been shown to be teratogenic in various animal models at doses 800-fold and greater than the maximum recommended human dose, based on body surface area (BSA). Due to the negligible human systemic exposure when used as recommended, it is not expected that maternal use of VisionBlue® 0.06% will result in fetal exposure to the drug and risk of teratogenic effects. Animal Data Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. Normalized to BSA, these doses are approximately 1,600- and 800-fold the maximum recommended human dose of 0.3 mg per injection (based on a 60 kg person), assuming complete systemic absorption of trypan blue. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 3,200-fold the maximum recommended human dose based on BSA, assuming total absorption). Lactation: the presence of trypan blue in human milk following intraocular administration has not been evaluated; no data are available regarding effects on milk production; breastfeeding is not expected to result in exposure of the child to trypan blue due to the negligible systemic exposure following injection and subsequent removal of the drug at the completion of surgical procedures.

Trypan Blue 0.06% (Ophthalmic)

Brand names: VisionBlue, Membrane Blue

Ophthalmic trypan blue is a vital dye used during cataract and other intraocular surgery to stain the anterior lens capsule and improve its visibility.

Adult dose

Dose: Cataract surgery — staining of the anterior lens capsule: VisionBlue 0.06% is carefully applied onto the anterior lens capsule with a blunt cannula after an air bubble is injected into the anterior chamber (supplied as a single-patient-use syringe filled to a volume of 0.5 mL); the label states no instilled volume

Route: Intraocular (applied onto the anterior lens capsule in the anterior chamber)

Frequency: Applied during cataract surgery after opening the eye, before the anterior capsulotomy is performed; excess dye is then irrigated out

Source: US prescribing information, VisionBlue 0.06% (trypan blue ophthalmic solution), Dosage & Administration (cataract surgery) and Indications: a diagnostic dye used as an aid in ophthalmic surgery by staining the anterior capsule of the lens. TECHNIQUE (label): after opening the eye, inject an air bubble into the anterior chamber to minimise dilution of the dye by the aqueous; carefully apply VisionBlue 0.06% onto the anterior lens capsule using a blunt cannula (a blunt cannula has to be attached to the syringe); sufficient staining is achieved as soon as the dye has contacted the capsule; irrigate the anterior chamber with balanced salt solution to remove all excess dye; an anterior capsulotomy can then be performed. NO VOLUME OR CEILING IN THE DOSAGE SECTION: the label gives the product strength (0.06%) and the 0.5 mL fill of the syringe but does not state how much of it to instil, and prints no maximum in the Dosage section; no ceiling is given here. The only dose-like figure in the label is a 'maximum recommended human dose of 0.3 mg per injection (based on a 60 kg person)', which appears in the Pregnancy section as a comparator for animal teratogenicity doses, not as a dosage recommendation. PAEDIATRIC (no numeric regimen, so paedDose is null): the label states that the safety and effectiveness of trypan blue have been established in pediatric patients, supported by an adequate and well-controlled study in pediatric patients. ELDERLY: no overall differences in safety and effectiveness between elderly and younger patients. No UK SPC for trypan blue is listed on eMC — this dose is from US prescribing information (VisionBlue 0.06%) and must be verified against UK practice.

Dose adjustments

Renal

The US label gives no renal dose adjustment; systemic absorption is expected to be negligible following injection and subsequent removal of the drug at the completion of the surgical procedure.

Hepatic

The US label gives no hepatic dose adjustment; systemic absorption is expected to be negligible following injection and subsequent removal of the drug at the completion of the surgical procedure.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Planned insertion of a non-hydrated (dry-state) hydrophilic acrylic intraocular lens (IOL) — the dye may be absorbed by the IOL and stain it

Side effects

Discoloration of high water content hydrogel intraocular lenses
Inadvertent staining of the posterior lens capsule and of the vitreous face — generally self-limited, lasting up to one week
Excessive staining (warning) if excess dye is not immediately removed from the eye by thorough irrigation of the anterior chamber

Clinical monograph

How it works

It selectively stains the basement membrane of the anterior capsule, providing contrast that aids capsulorhexis, especially when the red reflex is poor.

Prescribing in practice

It is for intraocular surgical use by trained ophthalmic surgeons only and must be handled aseptically to avoid endophthalmitis.
Excess dye should be removed from the anterior chamber to limit unnecessary exposure of intraocular tissues.
It is particularly useful in dense or white cataracts where capsule visualisation is otherwise difficult.

Monitoring

Monitoring is intraoperative and immediately postoperative, observing for corneal endothelial changes and signs of intraocular inflammation or infection.

Counselling the patient

This dye is used by your surgeon during the operation to help see structures inside the eye more clearly.
Report any increasing pain, redness or loss of vision after surgery promptly.

Evidence & guidelines

Capsule staining with trypan blue to assist capsulorhexis in challenging cataracts is well established in ophthalmic surgical practice.

Reference: ESCRS Cataract Surgery Guidelines; VisionBlue SPC; JCRS Review (Trypan Blue Safety); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways