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510(k) Data Aggregation

    K Number
    K013756
    Device Name
    ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)
    Manufacturer
    ARGUS BIOMEDICAL PTY LTD
    Date Cleared
    2002-08-29

    (289 days)

    Product Code
    HQM
    Regulation Number
    886.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARGUS BIOMEDICAL PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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