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Keratoplasty & corneal harvesting; Microlamellar keratoplasty

The Summit Krumeich-Barraquer Microkeratome is an automated version of the Eyetech-Barraquer-Krumeich Swinger Refractive Set found substantially equivalent under K954058. Other than the automated cutting action option of the electronic model, both microkeratomes share the following basic description. The Microkeratome is a medical "instrument" exclusively designed for use in ophthalmic surgery. This instrument should only be installed, used and serviced by suitably qualified personnel. The speed of forward movement during cutting and the frequency of oscillation of the blade can be individually set and controlled by the operator. The instrument will remain programmed until the data is overwritten by new data. For safety reasons the instrument is equipped with an electrical energy and vacuum reserve which is maintenance free. There is enough reserve energy and vacuum stored that in the event of an electrical failure or loss of main voltage at an inconvenient point in the procedure, the procedure can still be completed. The primary function of this instrument is to make a thin anterior corneal lamellar section leaving the cornea attached nasally by means of a hinge or to remove or harvest the cornea completely. The suction ring is responsible for positioning the microkeratome over the eye. The microkeratome has an oscillating blade, which, with a defined advancing speed (0.1 to 3.0mm/sec.) is guided over the cornea of the patient. The frequency of oscillation and the advancing speed of the blade greatly influence the quality of the cut surface.