Natarajan MacuSeal™ — Size‑Based Product Information 

Dehydrated Human Amniotic Membrane Allograft for Retinal Surface Coverage
361 HCT/P • 21 CFR 1271 • SAL 10⁻⁶ Gamma Sterilised

1. Product Overview

Natarajan MacuSeal™ is a single‑use, devitalised, dehydrated human amniotic membrane allograft engineered for temporary retinal surface coverage and structural scaffolding during vitreoretinal surgery.

Quoted line:

“Dehydrated … room‑temperature stable … terminally sterilised to SAL 10‑6 … individually packaged for single‑use intraoperative deployment.”

The allograft is available in multiple thicknesses and dimensions, enabling precise matching to posterior segment defect geometry.

2. Size‑Based Product Information

The PDF lists four primary thickness categories:
500 µm • 1000 µm • 1500 µm • 2000 µm

Each size supports a distinct surgical indication and defect profile.

A. 500 µm — Precision Micro‑Scaffold

Clinical Application

• Small to moderate macular holes
• Focal posterior pole defects
• Cases requiring minimal‑footprint scaffolding
• Ideal for inlay (plug) technique

Functional Advantages

• Thin, pliable, easy to position
• Conforms smoothly to small defect margins
• Minimal mass reduces risk of displacement during fluid‑air exchange

Procurement Relevance

• High‑turnover size for routine macular hole surgeries
• Suitable for centers with high volume of standard MH repairs

Quoted line:

“Ideal for small‑to‑moderate macular holes requiring precise, minimal‑footprint scaffolding.”

B. 1000 µm — Standard Versatile Option

Clinical Application

• Large macular holes (>400 µm)
• Standard overlay applications
• Retinal thinning or focal degeneration requiring broader coverage

Functional Advantages

• Balanced thickness for stability and flexibility
• Excellent conformability to posterior curvature
• Reliable performance during fluid‑air exchange

Procurement Relevance

• Most commonly used size across vitreoretinal practices
• Suitable for both routine and complex cases

Quoted line:

“Versatile mid‑range option for standard large macular holes (>400 µm) and routine overlay applications.”

C. 1500 µm — Extended Coverage for Complex Cases

Clinical Application

• Posterior pole defects with irregular margins
• PVR‑associated retinal repair
• Large macular holes requiring enhanced structural support

Functional Advantages

• Increased thickness provides robust mechanical stability
• Maintains position during extensive intraoperative manipulation
• Suitable for both inlay and overlay techniques

Procurement Relevance

• Essential for tertiary centers managing complex retinal pathology
• Supports advanced surgical workflows

Quoted line:

“Extended coverage for complex posterior pole defects and PVR‑associated retinal repair.”

D. 2000 µm — Maximum Coverage for Advanced Reconstruction

Clinical Application

• Giant retinal tears
• Large posterior pole defects
• Advanced reconstruction requiring broad biological coverage

Functional Advantages

• Highest structural mass for maximum defect coverage
• Maintains stability even during aggressive fluid‑air exchange
• Provides a wide biological interface for tissue remodeling

Procurement Relevance

• Critical for advanced vitreoretinal units
• Supports rare but high‑risk surgical scenarios
• Ensures readiness for complex trauma and PVR cases

Quoted line:

“Maximum coverage for giant retinal tears, large posterior pole defects, and advanced reconstruction.”

3. Common Features Across All Sizes

Regulatory & Safety

• 361 HCT/P under 21 CFR 1271
• Minimally manipulated structural tissue
• No living cells
• Not combined with drugs, biologics, or devices
• Local action only

Quoted line:

“Natarajan MacuSeal™ satisfies all five criteria of 21 CFR 1271.10(a) for regulation solely under Section 361.”

Processing & Sterility

• Devitalised, dehydrated
• Gamma sterilised to SAL 10⁻⁶
• Aseptic processing
• Room‑temperature stable

Donor Eligibility

• Full‑term live‑birth donors
• Medical Director‑supervised eligibility
• Infectious disease testing per 21 CFR 1271 Subpart C
• Full traceability

Intraoperative Handling

• Can be used dehydrated or briefly hydrated
• Trim‑to‑fit capability
• Suitable for inlay and overlay placement
• Stable during fluid‑air exchange

4. Procurement Summary (Size‑Driven)

5. Manufacturer

Akriti Ophthalmic Pvt. Ltd.
Medical Devices Park, Sultanpur Village
Patancheru Mandal, Hyderabad – 502319
Telangana, India
www.akritiophthalmic.com

Please read before purchase. The information provided regarding dietary supplements or ointments are not to be taken as medical advice.

Consult a healthcare professional prior to use if you are pregnant, nursing, taking medication, or have a medical condition.

Keep out of reach of children. Store in a cool, dry place. Do not use if seal under cap is broken or missing.

Order by 2PM to get delivered next working day! We use 24 hours service with carriers in most cases so that you can get your order delivered on time.

There is €4.99 charge for delivery under €50 Orders. Additional charges will be imposed by our couriers for delivery to remote area, a surcharge may be levied to cover carriage to these areas.

Please note: Exposure to heat or sunlight may lead to melting/damage of product. Hence customers are expected to be available during the product delivery.