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The Bio-eye Hydroxyapatite Ocular Implant is intended to be implanted in the eyeball to occupy space following removal of the contents of the eyeball. The Ophthalmic Conformer is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity during the healing process following surgery. The Bio-eye Hydroxyapatite Ocular Implant is indicated as a primary implant in cases of enucleation and evisceration, and as a secondary implant in cases of poor performance of a primary implant, such as in cases of poor motility, migration, extrusion, chronic infection, enophthalmos, and lid sag. The device is indicated in any situation where silicone, acrylic, polyethylene, glass, or other traditional ocular implants are used. The Conformer is indicated in all cases in which an orbital implant is used.

Both the Motility Orbital Implant and the Bio-eye Hydroxyapatite Ocular Implant are eye sphere implants manufactured of hydroxyapatite. The Bio-eve Hydroxyapatite Ocular Implant will now be provided sterile. The Ophthalmic Conformer is used in conjunction with the Ocular Implant for ocular prosthesis and will also be supplied sterile. The technological characteristics of the Ocular Implant are the same as the predicate: Both Implants are manufactured of porous hydroxyapatite. It is a synthetic hydroxyapatite which is similar in composition to the mineral content of human bone. The implant material has a unique interconnected porous matrix derived from specific marine corals. A patented manufacturing process preserves the porous structure of the coral while the calcium carbonate skeleton undergoes a hydrothermal chemical conversion to hydroxyapatite. The Bio-eye Hydroxyapatite Ocular Implant will now be supplied sterile. The Interpore 200 Porous Hydroxyapatite is identical to the Motility Orbital Implant described above. Interpore is the manufacturer and supplier of the Motility Orbital Implant. The Interpore 200 Porous Hydroxyapatite is sterilized by gamma radiation and is supplied sterile. The Ophthalmic Conformer, which is now 510(k) exempt (Federal Register 1-21-98), will now be supplied sterile.

The Perry-Kolberg Titanium Motility/Support System is intended to provide a direct mechanical coupling of an ocular prosthesis to an orbital implant (eye sphere implant) in order to enhance motility of the prosthesis over that of a prosthesis used without a direct coupling to the implant. It also reduces the weight of the ocular prosthesis on the lower eyelid. It may be placed in a secondary operation that occurs after the ocular implant has become vascularized, approximately three to six months after implant placement. Alternatively, it may be placed during the initial implantation procedure before closing the Tenon's capsule and the conjunctiva.

The Perry-Kolberg (PK) Titanium Motility/Support System consists of the PK Titanium Threaded Sleeve, the PK Titanium Flat Peg for Sleeve, the PK Titanium Locking Socket Peg for Sleeve, the PK Titanium Motility Ball Peg for Sleeve, the PK Titanium Threaded Sleeve Wrench and a scries of PK Titanium Needle Drill Handles. The latter two devices are Class I, exempt devices, and are included in this submission only for reference and to explain the use of the PK Titanium Motility/Support System. The Threaded Sleeve is an excernally threaded cylinder with an internal drilled hole designed to receive a peg. It is placed in the Bioeye® Hydroxyapatite Implant with the use of the PK Titanium Threaded Sleeve Wrench after a hole is prepared in the implant by drilling with a series of hypodermic needles of gradually increasing size, from 21-gauge to 14 gauge. The needles are held with the PK Titanium Needle Drill Handle. After the Threaded Slecve is placed in the implant, any of the PK Motility Pegs can be inserted. The PK Titanium Flat Peg for Sleeve can be used as a temporary device to maintain the integrity of the drilling hole or can, in some cases, be used to directly attach to the ocular prosthesis. The PK Titanium Locking Socket Peg for Sleeve is designed to aid in retention of a prosthesis even in extreme gazes by locking into the ocular prosthesis and avoiding the loss of engagement of the peg and the motility hole. It is manufactured with a shaft length that is adjustable in one millimeter increments by the ocularist, to mect each patient's individual requirements. A non-adjustable ball and socket peg, the PK Titanium Motility Ball Peg for Sleeve, is also included in the system.