CUSA Clarity Ultrasonic Surgical Aspirator System

• • Ongoing Z-1828-2026 FDA Class II ·initiated 6 Mar 2026

  Software issue that renders the touch screen unresponsive.

• • Terminated Z-0694-2018 FDA Class II ·initiated 26 Sep 2017

  A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently activated at start-up or at the initial use once the footswitch is connected to the console and after the user primes the system, performs a handpiece test, and enters the Main Screen. 2) Ultrasonic fragmentation may remain activated during surgical use once the foot pedal is disengaged slowly.

510(k) Number

K161882 ↗

FDA Product Code

LFL

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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