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The Boston KPro is indicated to provide a transparent optical pathway through an opacified cornea in an eye that is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.

The Boston KPro, Type I Lucia is an artificial corneal device that can be used in patients with severe corneal opacity. The device consists of two components: a front plate constructed of clear polymethyl methacrylate (PMMA) plastic, and a back plate constructed of titanium that locks the device in place around a corneal donor graft. The Boston KPro, Type I Lucia is supplied with an assembly tool/pin to assist in device assembly.

The Boston Keratoprosthesis is indicated to provide a transparent optical pathway through an opacified cornea in an eye that is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.

The Boston Keratoprosthesis is an artificial corneal device that can be used in patients with severe corneal opacity. The Boston Keratoprosthesis is used after standard corneal transplant has failed or when such a transplant would be unlikely to succeed. Thus, keratoprosthesis implantation is a procedure designed to help patients whose conditions are the most difficult to treat. This 510(k) seeks to modify the back plate material from PMMA to titanium. In doing so, the modified implant eliminates the need for a titanium retaining ring which was employed in the predecessors to hold the PMMA back plate in position following implantation. This also simplifies the assembly. It is available in two types. The Type I keratoprosthesis is implanted through and fixed only to the cornea and is used for corneal blindness when the eyelids, blink mechanism and tear film are intact. The Type II keratoprosthesis has an anterior extension to enable implantation through an opening in the closed eyelids. The Type II device is used in eyes with severe dry eye, mucosal keratinization and obliteration of the normal conjunctival fornices, such as after severe chemical injuries or Stevens Johnson syndrome or mucous membrane pemphigoid. Both devices are identical in terms of assembly.

Adult patients with corneal opacity not suitable for standard penetrating keratoplasty with donor tissues, or where donor tissue has been declined, or where adjunctive measures required to prevent graft rejection are medically contraindicated.

The AlphaCor artificial cornea is made of flexible hydrogel PHEMA and comprises an optically clear core surrounded by a peripheral opaque sponge rim, which allows tissue ingrowth. The core allows transmission of light and provides refractive power, while the sponge skirt allows fibrovascular ingrowht for long term securing of the device into place. The AlphaCor device is implanted in a two stage surgical process using a modified intrastromal lamellar technique that places the posterior surface of the optic in direct communication with the anterior chamber. covers the anterior surface of the optic with the anterior corneal lamella and, usually, a conjunctival flap, and places the skirt within the lamellar pocket. The second stage of the surgical process consists of opening the anterior covering layers about 12 weeks post-implant, which exposes the anterior surface of the AlphaCor optic and allows light transmission into the eye. The AlphaCor is available in two different powers: AlphaCor-A™ for aphakic eyes and AlphaCor-P™ for phakic and pseudophakic eyes. AlphaCor-A™ delivers additional positive power to compensate for the absence of a lens in the aphakic eye.