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Amniotic Membrane Allograft
Membrane Lite Restore - Ocular™
Single-layer amniotic allograft membrane
A single-layer amnion human tissue allograft derived from the amniotic membrane that serves as a barrier and provides protective covering for the ocular surface — minimally manipulated to preserve its natural-state properties, in compliance with FDA regulations.
Section 361 HCT/P
8 · 10 · 12 mm discs
Form
Disc sizes
Shelf life
Sterilization
Regulatory
Overview
A single-layer amnion membrane for the ocular surface
Membrane Lite Restore – Ocular is a single-layer amnion human tissue allograft derived from the amniotic membrane. It serves as a barrier and provides a protective covering for the ocular surface.
It is minimally manipulated, preserving the properties exhibited in its natural state, and remains compliant with FDA regulations as a Section 361 human cell and tissue product. Each membrane is tested for potentially infectious diseases and terminally sterilized.
Designed for
- Barrier & protective covering for the ocular surface
- Readily available for ordering
- Easy application
- Five-year shelf life
─ Product advantages
Barrier & protective covering
Serves as a barrier and provides a protective covering for the ocular surface.
Single-layer amnion
A single-layer human amnion allograft derived from the amniotic membrane.
Minimally manipulated
Minimally manipulated to preserve the properties exhibited in the tissue’s natural state.
Readily available
Stocked and readily available to order in 8, 10, and 12 mm discs.
Easy application
Designed for straightforward application to the ocular surface.
Five-year shelf life
A five-year shelf life supports flexible inventory and reduced waste.
Composition
A minimally manipulated, single-layer amniotic membrane
Membrane Lite Restore – Ocular is derived from the amniotic membrane and processed to remain minimally manipulated, preserving the properties exhibited in its natural state.
As a single-layer amniotic allograft, it provides a conformable barrier and protective covering for the ocular surface, consistent with the homologous use of amniotic membrane.
◆ Section 361 HCT/P · Minimally manipulated
─ Specifications
─ Quality & safety
Donor screening & safety
Tissue is recovered from screened, consented donors evaluated for eligibility in accordance with FDA requirements under 21 CFR Part 1271. Each membrane is tested for potentially infectious diseases and terminally sterilized to help ensure the safety of every membrane.
Communicable-disease testing · per 21 CFR 1271
Manufacturer's full test panel and accreditations available on request — to be confirmed with BioLab Holdings.
─ Application & handling
Inspect
Inspect the label and packaging. Do not use if the package is damaged or the seal is compromised.
Open aseptically
Open the packaging and transfer the membrane to the sterile field using aseptic technique.
Prepare
Prepare and orient the membrane in accordance with the product Instructions for Use.
Apply
Place the membrane onto the ocular surface as a barrier and protective covering.
Retain
Retain on the ocular surface in accordance with the product Instructions for Use.
These are general handling steps. Refer to the product Instructions for Use (IFU) for complete preparation, orientation, application, and retention instructions.
─ Clinical application
Membrane Lite Restore – Ocular is intended for homologous use as a barrier and protective covering that supports the ocular surface. Patient selection, clinical application, and use are determined by the treating qualified healthcare professional based on independent clinical judgment.
Indications and any efficacy statements are subject to regulatory/legal review prior to publication.
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