Additional information provided in d.9, h.3, h.6 and h.10 a review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Product was visually inspected and no obvious defects were found.Surgical residue was observed in the cassette aspiration chamber.The ball in the drip chamber¿s check valve moved freely per specification.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.The light emitting diode (led) rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.10000 cut rate displayed on the screen when the radio frequency identification (rfid) was connected to the console.The sample was tested using a system console.The sample could prime, tune with the ultrasonic handpiece, the 0.9mm air bypass (abs) tip and infusion sleeve from the lab stock, and passed intraocular pressure (iop) calibration successfully.Fluid flowed from the balanced salt solution (bss) bottle to the drain bag without any interfering.No air leak was detected from the infusion airline during priming process.No message code appeared on the screen.No leakage was found from the pump elastomer or onto the pump area of the fluidics module.The cleaning process was able to be performed after functional testing was completed.The sample passed functionality.The root cause of the complaint could not be established; the returned sample functioned per specifications.After an investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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