Natarajan MacuSeal™ — Allograft Tissue Information & Product Preparation Insert

A precision‑engineered dehydrated amniotic membrane ophthalmic patch designed for macular and retinal surface repair.

📦 Contents / How Supplied

This package contains Human Cellular and Tissue‑Based Products (HCT/P) as defined under US FDA 21 CFR Part 1271.

CAUTION: Federal (USA) law restricts this product to sale by, or on the order of, a licensed physician.

The donated human tissue has been determined eligible for transplantation by a licensed Medical Director according to the criteria listed in the Donor Selection section.

🔬 Product Description

Natarajan MacuSeal™ is a precision‑engineered dehydrated amniotic membrane ophthalmic patch designed specifically for macular and retinal surface repair.

Key characteristics:

• Circular geometries: 500, 1000, 1500, 2000 microns

• Dehydrated during processing; membrane appears visibly dry upon opening

• Terminally sterilized using E‑beam irradiation

• Packaged sterile for single‑patient, one‑time use

• Includes Tracing Record and patient labels

• Must be used immediately after opening

🏢 Introduction

Manufactured by Akriti Ophthalmic Pvt Ltd, registered with the US FDA as an HCT/P manufacturer. Distributed by Smart Technology LLC, USA.

🧬 Donor Selection & Eligibility

Donor eligibility is determined by a licensed Medical Director based on:

1. Donor Screening

Donor was free from risk factors and clinical evidence of infection due to relevant communicable diseases.

2. Donor Testing

Negative/nonreactive results for:

• HIV‑1 & HIV‑2 antibodies

• HIV‑1 / Hepatitis B / Hepatitis C (TMA)

• Hepatitis B surface antigen (HBsAg)

• Hepatitis B total core antibody

• Hepatitis C antibody (anti‑HCV)

• HTLV‑I & HTLV‑II antibodies

• Syphilis (FDA‑licensed tests)

• West Nile Virus (WNV NAT test)

All tests performed by FDA‑registered, CLIA‑certified laboratories.

3. Medical Record Review

Includes:

• Donor medical history

• Behavior risk assessment

• Physical examination

• Culture results at recovery

• Interviews with physicians or donor’s mother

All donor documentation can be retrieved upon request.

🧼 Recovery

Tissue recovery is performed aseptically, with medical records reviewed at the time of recovery.

🏭 Processing

Natarajan MacuSeal™ is processed in a controlled clean‑environment facility using validated methods designed to prevent contamination and cross‑contamination. Quality assurance standards are rigorously maintained.

🚚 Tissue Distribution

Distributed by: Smart Technology LLC, Cleveland, Ohio, USA

📦 Tissue Storage

Store Natarajan MacuSeal™:

• In original packaging

• At room temperature

• Until ready for use

🔗 HCT/P Tracking Requirements

To comply with FDA and Joint Commission standards:

• Record the allograft ID number in the operative record

• Complete and return the Tracing Record card

• Use included patient labels for documentation

🩺 General Usage

Natarajan MacuSeal™ serves as a biological sealant and protective barrier during repair of macular and retinal defects.

Indicated for:

• Macular hole closure

• Retinal tear reinforcement

• Retinal surface reconstruction

• Biological scaffolding during vitreoretinal surgery

⚠️ Precautions

1. Do not use in presence of active infection.

2. Donor screening may not detect all diseases.

3. Possible complications include:

   • Transmission of communicable diseases

   • Transmission of infectious agents (viruses, bacteria, fungi)

   • Immune rejection or allergic reaction

🚨 Adverse Reactions

Report any adverse reaction immediately to: Akriti Ophthalmic Pvt Ltd Customer Service 📞 +1‑216‑239‑9880

🛠 Recommended Instructions for Use

(General guidelines; not a substitute for clinical judgment)

Preparation

1. Open carton and remove foil pouch.

2. Peel outer foil pouch; remove sterile inner aluminum pouch.

3. Open inner pouch and place implant into sterile field.

Handling Notes

• Graft is lightweight; handle carefully.

• Translucent off‑white/yellowish appearance is normal.

• A dry recipient surface improves adherence.

Placement

• Remove graft from pouch

• Position at desired anatomical site

• Secure using physician’s preferred fixation method

↩️ Return Policy

• Return Authorization (RA) required

• Product must be unopened and in resalable condition

• Contact Smart Technology LLC Customer Service

📜 Product Information Disclosure

Smart Technology LLC excludes all warranties, expressed or implied, including merchantability or fitness for a particular purpose. Not liable for incidental or consequential damages.