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 the returned sample was visually inspected and no obvious defects were found.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.The administration manifold was not returned.A pressure leak test was then conducted on the cassette utilizing an external pressure source and no cassette leakage was detected.A calibrated constellation console representing the current software version was used to test the sample with the lab stock administration manifold.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.The sample could prime, tune with the ozil handpiece, and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.Fluid flowed from the bss bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The presence of fluid leaking from the cassette was not confirmed.After both leakage and console laboratory testing, inspection of the sample indicated no signs of continued leakage from the pump elastomer or cassette.Furthermore, there were no signs of fluid leakage onto the fluidics console due to leakage from the cassette.The cassette passed functional and performance testing.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.After final assembly each cassette is verified that all required tests have been performed and all acceptance criteria are met prior to release.The manufacturer internal reference number is: (b)(4).
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