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Alcon LenSx, Inc. - Common Name: LenSx Laser System. - Class 2 Recall

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Trade Name: LenSx Laser. Classification Name: Class II Ophthalmic Laser. The LenSx Laser System introduced in August 2011 is intended for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation. The Patient Interface (PI) is inserted onto the delivery system for each new procedure and serves to hold the eye in the correct position for the laser procedure. During the set up phase of the procedure, the contact lens of the PI is docked onto the patient s eye by moving the gantry, which is controlled by a joystick. 510(K) Number: K123120 Device Listing Number: D204425

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