OptiCover
Ringless, lyophilized amnion membrane disc allograft
Ringless
12 mm disc
Room-temperature stable
Gamma · SAL 10⁻⁶
Section 361 HCT/P
Form
Ringless disc
Size
12 mm
Storage
Room temp
Sterilization
Gamma · SAL 10⁻⁶
Regulatory
Section 361
Overview
A ringless amnion disc for the ocular surface
OptiCover is a ringless, lyophilized human amnion membrane disc allograft — aseptically processed, devitalized, and terminally sterilized — manufactured from consented donor birth tissue under cGTP and cGMP. It is designed to support homologous use in ocular surface management.
The lyophilized format is shelf-stable at room temperature, removing cold-chain and freezer requirements, and its natural adhesive characteristics allow it to be retained on the ocular surface beneath a bandage contact lens (BCL) or collagen shield.
Designed for
- Patient comfort — ringless format
- Room-temperature storage and handling
- Retained native membrane architecture
- Retention beneath a BCL or collagen shield
- Product advantages
Ringless design
A ringless disc format intended for patient comfort and straightforward placement on the ocular surface.
Room-temperature stable
Lyophilized for shelf-stable storage — no freezer or cold-chain logistics required.
Native architecture preserved
AGNES™ processing retains the spongy and amnion layers, including Type IV collagen and the HC-HA/PTX3 complex present in native placental tissue.
Enhanced structural integrity
Designed for greater structural integrity than conventional dehydrated amniotic membranes.
Terminally sterilized
Gamma-irradiated to a sterility assurance level (SAL) of 10⁻⁶. Single-use, for qualified professionals.
BCL & collagen-shield compatible
Natural adhesive characteristics allow retention beneath a bandage contact lens or collagen shield.
AGNES™ processing, native architecture preserved
OptiCover is processed using AGNES™ technology, which retains the spongy layer along with the amnion layers and preserves the inherent components of native placental tissue, including Type IV collagen and the HC-HA/PTX3 complex.
Immunohistochemical (IHC) staining for Type IV collagen demonstrates retention of basement-membrane components, confirming preservation of the membrane’s native structural architecture.
Figure 1 — Retention of Type IV collagen (basement membrane)
Representative illustration · insert IHC figure
AGNES™ Processing Technology
Figure 1 — Retention of Type IV collagen (basement membrane)
Representative illustration · insert IHC figure
Donor screening
Every donor is evaluated by the Medical Director — including infectious-disease test review, informed-consent verification, detailed medical and behavioral history, physical examination, and review of medical records — with tissue recovered from consented donors under cGTP and cGMP.
- Application instructions
Inspect
Inspect the label and outer pouch. Do not use if the pouch is damaged or the seal is compromised.
Open outer pouch
Open the outer foil pouch and present the inner pouch to the sterile field using aseptic technique.
Retrieve
Open the inner pouch to retrieve OptiCover. The stromal side is packaged face-up; the epithelial side faces the metallic pouch.
Hydrate
Hydrate with sterile saline, sterile water, or balanced salt solution prior to application.
Apply & retain
Place the epithelial side onto the BCL/collagen shield, stromal side toward the cornea; use a BCL or collagen shield to retain on the ocular surface.
- Application instructions
OptiCover is intended for homologous use as a biologic covering that supports the ocular surface. Selection of patients, 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.