Button control
Designed to deliver smooth, controlled fluid extraction with minimal force.
DISCOVER OCUTAP
Engineered with diagnostic yield and procedural risk in mind.
A closed-system, single-use device designed for anterior chamber paracentesis in uveitis and other anterior segment diagnostics, with a detachable vial that ships directly to the lab.
THE CLINICAL NEED
The disease burden of uveitis is significant
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4 million
new cases globally each year
A large, recurring population needs reliable anterior-chamber sampling.
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3rd
leading cause of blindness in the US
Faster, better-characterized diagnosis can protect sight.
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41.5%
had an underlying infection
Molecular sampling helps identify the cause, not just the symptom.
The constraints of current eye fluid sampling
Anterior chamber paracentesis is a high-skill, two-handed procedure performed with a standard syringe and a long needle. The handling is awkward, the sample yield is variable, and a meaningful portion of what is collected is lost during transfer for shipping.
Where clinicians struggle
The standard syringe introduces measurable friction across every procedural phase. In surveys of retina, uveitis, glaucoma, and anterior-segment specialists, the same pain points recur, and each carries a number.
Percentages reflect the share of surveyed clinicians reporting each issue.
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56%
Difficult to maneuver
One-handed control remains elusive with a standard syringe. Stabilizing the eye while drawing fluid demands two hands and steady nerves.
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54%
Limited lab acceptance
Not all labs accept samples collected in traditional syringes, delaying diagnosis and forcing device compromises.
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51%
Concern for injury
Needle-stick exposure and injury to adjacent tissue remain persistent concerns during collection and transfer.
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38%
Post-procedure wound leak
Wound leakage after the tap adds risk and follow-up burden.
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26%
Magnification required
Monitoring the needle often requires added magnification for control.
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25%
Needle length raises risk
A long needle increases the risk of injury during the procedure.
The future of ophthalmology is molecular
Aqueous molecular biomarkers are moving from research into practice, and reliable ocular fluid sampling is the bottleneck OcuTap is built to remove.
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75%
of surveyed physicians are highly interested in using aqueous molecular biomarkers to guide treatment selection.
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21→38%
growth in molecular-biomarker use in trials over the last decade.
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5×
higher drug-approval rates in programs that use molecular biomarkers.
THE SOLUTION
A device built for the procedure room
The OcuTap is a single-use paracentesis device designed to simplify aqueous humor extraction with a detachable vial that ships directly to the lab, eliminating manual sample transfers.
- Designed for one-handed control
- Designed to reduce the need for an assisting hand
- Closed-system design intended to maintain sterility
Device at a glance
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No calibration needed
A factory-set mechanism is engaged before patient contact, intended to remove the operator’s draw speed as a variable.
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Luer hub
Designed for compatibility with standard needles, for quick and secure attachment.
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Easy & swift disposal
Designed for straightforward disposal — insert the device into a sharps container after vial removal.
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Ergonomic grip
Designed to support stability during precise micro-maneuvers.
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Polypropylene vial
This clear, sterile sample tube is designed for broad compatibility with diagnostic laboratories.
Instructions for use
Watch the video demonstration of the OcuTap procedure or follow the detailed, step-by-step instructions.
The following protocol outlines the intended engineering functionality of the OcuTap device. These instructions are provided for informational and investigational purposes only, pending official regulatory clearance.
Procedure video
Video transcript
The OcuTap has been carefully crafted to improve comfort, control, and efficiency for liquid biopsy of ocular fluid.
First, the device is primed by pulling back the collection tube to an extended position. A click will sound to lock it into place. A needle is attached.
The device is inserted into the eye at the limbus following standard procedures for anterior chamber paracentesis. Collection of the fluid is started with depression of the central button. This opens the valve and allows for steady, smooth, and reliable fluid collection. The users can release the button to stop the fluid if needed.
The system’s design prevents fluid or pressure spikes during collection, and the one-handed operation improves physician control during the procedure, which improves safety for the patient and limits complications.
When the procedure is complete, the button is released and the device is safely withdrawn from the eye. A final push of the button clears the fluid from the internal pathway of the device into the collection tube.
The procedure is complete when the collection tube is twisted to remove it from the device. The device is discarded safely in the sharps container, and a cap is placed on the collection tube for shipping.
Procedure steps
Attach Needle
Securely attach a sterile needle (not included) to the device. Do not remove the needle cap at this time.
Prime the Device
Pull back the collection tube until it reaches an extended position and clicks into place.
Uncap Needle
Carefully remove the protective cap from the needle, ensuring the tip remains sterile and does not come into contact with any surrounding surfaces prior to insertion.
Insert & Collect Fluid
Insert the device into the eye at the limbus, strictly following standard anterior chamber paracentesis procedures. Once safely positioned, depress the central button to open the valve and begin the collection of fluid. If necessary at any point, release the button to immediately stop the fluid flow.
Withdraw Device
Once the collection is finished, release the button and carefully withdraw the device from the eye.
Clear Internal Pathway
Give the button a final push to move any remaining fluid from the internal pathway into the collection tube.
Remove Collection Tube
Twist the collection tube to detach and remove it from the primary device.
Dispose and Secure
Cap the barrel, and safely discard the syringe body in a sharps container. Place a cap securely on the collection tube for shipping and analysis.
PRELIMINARY INTERNAL DATA
Early testing suggests reduced fluid loss and consistent draw rates
Findings below are from an internal assessment of anterior chamber procedures. Not independently validated by a third party. Data on file.
Early testing suggests ~37% less fluid loss
Compared to standard 32-gauge needle technique (10.03 µL vs. 16.05 µL).
Draw rate
In internal testing, OcuTap delivered an average draw rate of approximately 40 µL per second, independent of operator technique.
Early pilot feedback
In an early pilot study, most participating clinicians reported a preference for OcuTap over the standard of care for control and safety. Preliminary data; not independently validated.
Designed by an ophthalmologist, for ophthalmologists.
OcuTap was developed by a practicing retina specialist and refined with feedback from clinicians who tried it during early development. Here’s what they shared:
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Dr. Ian ConnerUPMC Glaucoma chair“The actuation is controlled and measured, unlike a syringe that can pull fluid too fast, a real safety concern.”
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Dr. Thierry VerstraetenRetinal specialist“Not a microliter is wasted, nothing stays behind in the chamber.”
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Dr. Karen LaurenGeneral ophthalmologist“The device steadies your hand and lets you draw fluid without fumbling, that’s the real advantage.”
CAUTION—Investigational device. Limited by Federal law to investigational use. FDA 510(k) clearance anticipated by the end of 2026.
SAFETY & REGULATORY
510(k) clearance pending
FDA review underway for market clearance
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Ophthalmic syringe class II device
Classified under 21 CFR (Code of Federal Regulations) 880.5570 with product code QYL. Standard regulatory pathway for single-use ophthalmic aspiration devices.
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Under FDA review currently
CAUTION—OcuTap is investigational and limited by Federal law to investigational use. Regulatory submission is progressing through standard FDA pathways.
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Anticipated clearance by end of 2026
We are targeting FDA 510(k) clearance by the end of 2026.
What are indications for use?
OcuTap is indicated for collection of aqueous humor samples from the anterior chamber in patients with anterior uveitis, infectious keratitis, endophthalmitis, or other anterior segment inflammatory or infectious conditions requiring diagnosis.
Are there contraindications?
OcuTap is contraindicated in patients with corneal scarring or opacity that prevents adequate visualization of the anterior chamber. Use is also contraindicated in patients with shallow anterior chambers where safe needle placement cannot be assured.
What warnings apply?
Risk of corneal abrasion, hyphema, or lens trauma exists with improper needle placement. Infection or endophthalmitis may occur despite sterile technique. Hypotony or anterior chamber collapse can result from excessive fluid withdrawal.
What precautions should be taken?
Maintain strict aseptic technique throughout the procedure. Verify device integrity and sterility before use. Monitor intraocular pressure and anterior chamber stability post-procedure. Counsel patients on post-procedure care and signs of complication.
Disclaimer: Visionaire Products is responsible only for the performance of its devices as intended for specimen collection. Following successful specimen collection and transfer, all aspects of specimen handling, storage, transportation, laboratory testing, analysis, reporting, and disposal are the responsibility of the user and/or receiving laboratory. Visionaire Products assumes no liability for events occurring after specimen collection.
RESOURCES
Clinical downloads & IFU
Instructions for use, a clinical snapshot, and detailed device specifications available on request.
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Instructions for use and device setup
Complete step-by-step guidance for safe device preparation and operation.
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Clinical snapshot
A concise overview of device design, performance data and how it fits your clinical workflow.
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Device specifications
Detailed engineering and performance specifications. Contains proprietary information and is shared by request rather than published. Request permission and we'll add your email with viewing permission, then send you the link.
Stay informed on OcuTap’s regulatory progress.
OcuTap is pending FDA clearance, anticipated by the end of 2026. Sign up to get updates and we’ll email you when there’s meaningful news to share.
REFERENCES & CITATIONS
- 4 million new uveitis cases globally each year.Thorne, J. E., et al. (2016). Incidence and prevalence of uveitis within a large managed care population. American Journal of Ophthalmology, 170, 118–125.
- Uveitis as the third leading cause of blindness in the United States.UCI Gavin Herbert Eye Institute. (2024). Uveitis Clinical Overview & Patient Care. University of California, Irvine. ophthalmology.uci.edu (opens in a new tab)
- 41.5% of uveitis cases with an underlying infection.Wikidoc Uveitis Repository. (2024). Localized geographic/panuveitis cohort variant baseline.Suttorp-Schulten, M. S., & Rothova, A. (1996). The possible impact of uveitis in blindness: a literature review. British Journal of Ophthalmology, 80(9), 844–848.
- Clinician-reported barriers to the current standard of care, including the six figures in “Where clinicians struggle”.Visionaire Products, Inc. (2024). Clinician Sentiment and Barriers to Standard Ocular Paracentesis: A Double-Blind Specialist Survey [Unpublished Internal Report]. Data on file.
- 75% of surveyed physicians highly interested in aqueous molecular biomarkers.Ophthalmic Biotech Insights Group. (2024). Aqueous Humor Molecular Biomarkers: Physician Sentiment, Adoption Barriers, and Clinical Practice Integration Survey [Industry Report]. Boston, MA.
- Molecular biomarker use in trials rising from 21% to 38%, 2014–2024.Mikulic, M. (2024). Share of new molecular entities (NMEs) approved by the FDA that integrated molecular biomarkers from 2014 to 2024. Statista Biotech & Pharma Database.
- Five-fold higher drug-approval rates in programs using molecular biomarkers.Parker, J. L., et al. (2021). Does biomarker use in oncology improve clinical trial failure risk? A transition probability model. Cancer Medicine, 10(6), 1955–1963.
- 37% less fluid loss; 40 µL/second draw rate; 90% physician preference; n = 150 anterior chamber procedures.Visionaire Products, Inc. (2025). Evaluation of a Novel Single-Handed Microfluidic Device: Quantitative Performance and Key Opinion Leader (KOL) Advisory Assessment [Commercial Assessment Report]. Data on file.
- Regulatory classification and 510(k) status.U.S. Food and Drug Administration. Ophthalmic device classification, 21 CFR 880.5570, Class II, product code QYL.