No calibration needed
Attach the needle, prime the collection tube, and sampling begins with the press of a button.
ANTERIOR CHAMBER PARACENTESIS, SIMPLIFIED
Built for one-handed ocular fluid sampling, designed to lose less along the way.
OcuTap™ is a single-use device for anterior chamber paracentesis. It’s designed to replace the two-handed syringe technique with one-handed, button-controlled operation and a vial built to ship straight to the lab.
PRELIMINARY INTERNAL DATA
Results that matter
In anterior chamber paracentesis, the usable sample is often just a few microliters, so every microliter retained, and every variable removed from the draw, changes what the lab can actually test. Early testing suggests OcuTap may help on both fronts. Findings below are from an internal assessment, not independently validated by a third party. Data on file.
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~37%
less fluid lost per procedure
Early testing suggests less fluid is lost per procedure, meaning more usable volume may reach the lab.
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40 µL/s
consistent, pre-set draw rate
Early testing suggests a controlled, pre-set draw rate that may help remove operator speed as a variable.
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90%
physician preference
In an early pilot study, participating clinicians reported a preference for OcuTap over the standard of care for control and safety. Preliminary data; not independently validated.
Designed for controlled eye fluid sampling
OcuTap is designed to remove the two-handed fumble and reduce the sample loss that can follow. One button. One hand. One vial built to ship straight to the lab.
OcuTap compared with the standard syringe
| Feature |
OcuTap
|
Current standard
|
|---|---|---|
| Operating mode | One-handed | Two-handed |
| Preparation | Attach needle and prime collection tube | Variable |
| Fluid handling | Closed-system, direct-to-lab vial | Requires manual transfer |
| Sample integrity | Vial ships directly to lab | Requires manual transfer |
| Regulatory status | 510(k) pending | Established |
| Draw rate | Pre-set, consistent | Variable |
| Needle compatibility | Yes | Yes |
| Calibration | Not required | Required |
Designed by an ophthalmologist,
for ophthalmologists.
OcuTap was designed by a practicing retina specialist around the realities of the procedure room, not a lab bench, 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.
Key benefits of OcuTap
Every element was engineered to reduce friction and improve outcomes. OcuTap’s architecture reflects what clinicians need in the moment.
Four changes that matter
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Button-controlled draw for single-handed operation
A controlled, pre-set draw designed to free both hands for stabilization.
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Removable sample vial ships to lab
Vial detaches after sampling and is designed to ship directly to the lab, without a manual transfer step.
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Luer hub works with standard needles
32G ½″ needle compatibility. No new inventory. Integrates into existing workflow.
How OcuTap works
A high-level overview of the OcuTap procedure. For complete, step-by-step guidance, watch the full procedure video or download the official IFU.
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.
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Prepare and Prime
- Securely attach a sterile needle (not included) to the device. Do not remove the needle cap at this time. Pull back the collection tube until it clicks into place to prime the instrument.
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Collect
- Insert at the limbus and press the button to begin collecting fluid — release anytime to stop.
- When finished, release the button and withdraw the device.
- Press once more to clear remaining fluid into the collection tube.
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Detach and Secure
- Twist to detach the collection tube from the syringe body.
- Cap the tube for shipping and lab analysis.
- Dispose of the syringe body in a sharps container.
Assembled in the USA
Availability
OcuTap is built to fit your current practice workflow. Anterior chamber paracentesis already has a Current Procedural Terminology (CPT) code (65800), and adopting OcuTap is intended to require no new protocols for staff to learn. Availability follows FDA 510(k) clearance, anticipated by the end of 2026.
- Single-use, sterile, individually packaged
- Anterior chamber paracentesis already has a CPT code (65800)
- Planned for direct ordering at launch
Common questions
Is OcuTap currently available?
Not yet. OcuTap is an investigational device pursuing FDA 510(k) clearance, anticipated by the end of 2026. Ahead of clearance, it is available to qualified investigators under the applicable FDA pathway. Get updates to be notified when it’s available.
What samples can be collected with OcuTap?
OcuTap collects aqueous humor from the anterior chamber of the eye — an anterior chamber paracentesis. The anticipated indication is limited to the anterior chamber; it does not cover vitreous sampling.
What is the device’s regulatory classification?
OcuTap is being submitted as an ophthalmic syringe — 21 CFR (Code of Federal Regulations) 880.5570, Class II, product code QYL — via the 510(k) pathway. Clearance is anticipated by the end of 2026.
Recent updates
Stay informed on OcuTap milestones and industry developments.
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FDA 510(k) clearance pathway and timeline
510(k) application submitted — an exciting milestone for OcuTap. This product answers current demand from users, and will set a new standard in anterior chamber paracentesis starting with adoption through clinical trials this year.
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OcuTap at the Ophthalmology Innovation Summit
Leanne Labriola, founder and CEO of Visionaire Products, presented updates on OcuTap — a device for anterior chamber paracentesis that can usher in the frontier of molecular biomarker use in ophthalmology.
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Uveitis podcast: limitations of current diagnostics
Uveitis specialists recommend anterior chamber paracentesis to properly diagnose anterior inflammation.
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
- ~37% less fluid lost per procedure; 40 µL/second draw rate; 90% physician preference.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.
- Comparison with the current standard of care, including operating mode, preparation and fluid-loss risk.Visionaire Products, Inc. (2024). Clinician Sentiment and Barriers to Standard Ocular Paracentesis: A Double-Blind Specialist Survey [Unpublished Internal 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.