PDF document
Instructions for use and device setup
Complete step-by-step guidance for safe device preparation and operation.
Resource Center
Downloads and answers to frequently asked questions about OcuTap.
Downloads
Clinical resources
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PDF document
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.
Press kit
Fact sheet, team bios, and brand assets are shared together as one request. Request permission and we'll add your email with viewing permission, then send you the link.
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Fact sheet
Device specifications and technical performance data.
Included in the Press kit request
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Team bios
Headshots and professional bios for the full Visionaire team.
Included in the Press kit request
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Brand assets
High-resolution device photography, logos, and brand identity files.
Included in the Press kit request
Videos and renders
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Video & transcript
Procedural video with full transcript
Captioned demonstration of anterior chamber paracentesis technique using OcuTap.
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Interactive image
3D device examination tool
Rotate and inspect OcuTap components from every angle.
FAQ
Intended-use disclaimer: OcuTap is intended only for the collection of aqueous humor from the anterior chamber using a standard anterior chamber paracentesis procedure by trained ophthalmologists. Following successful collection and transfer, all specimen handling, storage, transport, 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 and transfer, or for any use outside this intended use.
Availability
When will OcuTap be available?
U.S. Food and Drug Administration (FDA) 510(k) clearance is anticipated by the end of 2026. Get updates and we’ll email you the moment OcuTap is available.
Is OcuTap single-use?
Yes. Each unit is single-use and sterile. Attach the needle and prime the collection tube — no calibration needed. Each device is discarded after one use, eliminating cross-contamination risk.
What sample types can OcuTap collect?
OcuTap is purpose-built for anterior chamber paracentesis, collecting aqueous humor for biomarker analysis. The removable sample vial detaches and ships directly to the laboratory.
What is OcuTap’s regulatory classification?
OcuTap is classified as a Class II medical device under FDA regulations (21 CFR (Code of Federal Regulations) 880.5570, product code QYL). It is intended for use by qualified, trained ophthalmologists.
How much fluid does OcuTap collect?
OcuTap delivers a controlled draw rate of 40 µL per second, enabling rapid, controlled collection of aqueous humor, with a maximum collection capacity of 1.25 mL.
Procedure
What patient preparation is required?
Standard ophthalmic preparation applies. Topical anesthesia and antiseptic are used as with conventional paracentesis. OcuTap requires no additional patient prep beyond routine anterior segment procedures.
Can OcuTap be used in all anterior segment cases?
OcuTap is indicated for anterior chamber paracentesis in cases where aqueous humor sampling is clinically appropriate. Contraindications follow standard ophthalmic guidelines for paracentesis.
How is the sample transported to the lab?
The removable sample vial detaches from OcuTap, must be capped, and ships directly to the laboratory. Capping the vial before shipping preserves biomarker integrity and prevents leakage during transport.
Workflow
Can multiple samples be collected with one device?
No. OcuTap is single-use. Each device collects one sample and is then discarded, ensuring sterility and eliminating cross-contamination risk.
What training is needed to use OcuTap?
OcuTap is designed for trained ophthalmologists already experienced in anterior chamber paracentesis. Standard ophthalmic technique applies; the device itself requires minimal additional training.
What about needle gauge?
OcuTap uses a 32-gauge needle optimized for anterior chamber access. This gauge balances sample yield with chamber stability, reducing the risk of iris or lens contact during collection.
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
- Regulatory classification and anticipated 510(k) clearance referenced throughout the FAQ.U.S. Food and Drug Administration. Ophthalmic device classification, 21 CFR 880.5570, Class II, product code QYL.
- 40 µL/second draw rate and 32-gauge needle specification.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.
- Clinician-reported barriers to the current standard of care.Visionaire Products, Inc. (2024). Clinician Sentiment and Barriers to Standard Ocular Paracentesis: A Double-Blind Specialist Survey [Unpublished Internal Report]. Data on file.