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The xact™ foldable lens inserter is a device intended to fold the AVS 3-piece foldable lens, 6mm or 7mm optic, and assisting in placing it into the capsular bag of the eye to replace the natural crystalline lens during normal smallincision cataract surgery. It provides a small tubular pathway in which the foldable lens can be placed into the eye with a continuous forward motion.

The xact lens inserter (Model 6mm / 7mm) is a light weight plastic, single use, disposable device. It has a multi piece design, with an injector/handpiece unit and a separate cartridge. The lens is delivered manually by action of the plunger. The final delivery is done by a screwthread action. The final injection needs 2- 3 turns with screw thread until the final position of the plunger. The plunger allows for forward and backward action during delivery. The front end of the plunger is visible during delivery. The lens inserter (Model 6mm / 7mm) is for both handed use: one hand for gripping and directing, while activating the plunger with the other. The plunger doesn't rotate inside the handpiece. The lens is rolled rather than folded. The cartridge or rolling/folding mechanism locks in place on the handpiece.

The CM3910 is a device intended to take images of the anterior segment of the eye which includes the cornea, iris, pupil, anterior chamber and lens, to evaluate and analyse - · Corneal shape - · Lens shape - · Pachymetry (thickness of the cornea) - · Pupil size - · Lens thickness - · Condition of the lens - o Location of cataracts (nuclear, subcapsular and or cortical), using Scheimpflug slit imaging with densitometry - State of the lens (opaque crystalline lens) o - · Condition and position of implants (e.g. iOLs, phakik IOLs, intracorneal rings) - · Anterior chamber (size, volume and angle) - · Scheimpflug Image - · Position of the cornea relative to iris and lens

The CM 3910 Double-Scheimpflug Camera is a non-invasive, diagnostic system designed for the analysis of the anterior eye segment by means of Scheimpflug and Placido images. The Scheimpflug images are based on the Scheimpflug Principle for Slit Image photography. The system is table mounted and AC powered. The device consists of a measurement unit and a control unit with a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for taking images. The measuring unit takes pictures by a rotating scan of the anterior eye segment. It also includes a top view for eye tracking means and Placido imaging in the near infrared. From the acquired pictures, the control unit calculates a 3D-model and the topography of the eye.

The Amadeus II Epikeratome is intended for use in performing lamellar corneal resections. This is the same intended use as previously cleared for the Amadelis microkeratome, K993190. The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

The Amadeus II Epikeratome is a modification of the ACCM/Amadeus Microkeratome, which is firmly established in the market for several years. In the course of a product update, the designs of blade and blade holder have been modified to provide surgeons with the option to perform Epi-LASIK. The surgical principles of the Amadeus II Epikeratome and its predicate device are essentially identical. To perform a lamellar corneal resection, the cornea is held in position by means of a suction ring, and vacuum is applied to increase intraccular pressure to a level allowing the epikeratorne blade to move across the cornes in a mode similar to that of a carpenter's plane. The corneal flap is made by the same open ating principle as in the predicate device, i.e., a blade is advancing and simultane opelva oscillating horizontally and perpendicular to the advancement direction. A Control Unit provides power and a controlled vacuum for fixing the eye. The comeal flap created by the epikeratorne consists of the entire epithelium, while in the predicate device it consists of the entire epithelium plus parts of the stroma. This difference in flap structure is obtained by modifications of the blade and thre hlade holder. Like its predicate device, the Amadeus II Epikeratome comprises three major groups of components: - a) A Handpiece, incorporating the Suction Unit, the Blade Holder, the Epikeratome Epi-A handpiece, IntoSperating theit. The Handpiece offers several safety features designed to prevent product malfunction or incorrect use, and allows the surgeon to handle the Epikeratome with only one hand. - b) A Control Unit with touch-screen interface, managing the epikeratome's cutting A Gontrol Only With toutic documentation of the chosen cutting parameters and user interface dialogs. - c) Two footswitches that serve to actuate and discontinue the epikeratome cutting r wo rocedure. The standard actuation footswitch serves to initiate suction and the epikeratome cutting action. Disposable components of the Amadeus II Epikeratome system are 1) a sterile plastic epikeratome blade and 2) a sterile vacuum tubing kit. Additionally, an autoclavable instrument tray is provided for sterilization.