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The AlphaSphere Orbital Implant is intended to replace orbital volume after loss of an eye through enucleation or evisceration, including secondary implantation after removal of an existing, unsatisfactory, orbital implant. The device is indicated in any situation where silicone, acrylic, polyethylene, coral, glass, or other traditional orbital implants are used.

The AlphaSphere Orbital Implant is aspherical orbital volume replacement prosthesis with a posterior gel hemisphere resistant to tissue ingrowth and an anterior hemisphere with a spongy outer surface designed to encourage tissue attachment. The implant is made entirely of a flexible hydrogel, poly (2-hydroxyethyl methacrylate). (PHEMA). The physical differences between the gel and spongy portions of the implant are created by varying the conditions during the hydrogel polymerization process. The transition between the two hydrogel regions is reinforced with a biocompatible synthetic mesh (MERSILENE) beneath the device surface to improve mechanical strength for the passage of sutures.