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The EK Delivery Device is to be used by ophthalmic surgeons trained in Endothelial Keratoplasty (EK) procedures and trained in the use of the EK Delivery Device as: - An aid facilitating the insertion of donor corneal posterior lamellar endothelial graft of 100 – 220 µm of thickness into the anterior chamber of the eye during endothelial keratoplasty. - For use in a 5.1 mm or larger incision and a maximum donor tissue diameter of ≤ 8.5 mm) - For loading and storage of donor tissue during transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 72 hours.

The Endothelial Keratoplasty Injector is a single-use, disposable device that allows an ophthalmic surgeon to insert a previously prepared disc of posterior donor cornea into the eye of a recipient patient through a small incision during a posterior comeal transplant surgical procedure. The function of the device is to insert the flat disc of donor comeal tissue within a cylindrical tube that is sized to fit into 5.1 mm or larger corneal or scleral incision, and to pull or push this donor corneal tissue into the anterior chamber of the eye as part of a Endothelial Keratoplasty procedure. This device was designed to insert donor posterior corneal tissue ≤ 8.5 mm in diameter, 100um to 220um in thickness, through a 5.1 mm or larger corneal incision. The EK Delivery device consists of four components: (1) the Trocar which is used to hold the graft material and introduce it into the anterior chamber of the recipient eye, (2) the Trocar Holder, which is used to close the proximal end of the Trocar and as an ergonomic handle to aid the surgeon handling the device, (3) the Injector Assembly, which is a plunger to push the endothelial keratoplasty tissue out of the Trocar and into the anterior chamber of the recipient eye, and (4) End Plug used during shipping. Delivers a circular endothelial tissue button in a rolled configuration.