DEVICE: Bio-Eye® (00854066006052)

An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device.

An implantable ocular device designed as an external cover (a wrap) for an orbital implant used in enucleation surgery, and to protect the surrounding orbital tissue from the surface of the implant. It is typically made of materials available in sheet form [e.g., polylactide (PLA), hydroxyapatite] that can be cut to the desired shape and size. It may be made malleable by submersion in hot water, after which it can be formed to any three-dimensional (3-D) anatomical orientation. It will typically contain pores that allow for natural vascular tissue ingrowth.

An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.