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.An infusion manifold was returned.The returned sample was visually inspected, and no obvious defects were found.A calibrated console representing the current software version was used to test the sample.The sample was tested with a lab stock posterior cassette.The sample could prime and pass intra ocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.Fluid flowed from the balanced salt solution (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.The infusion pressure was measured at multiple set points and met specifications.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.Cleaning process was able to be performed after functional test had completed.The root cause of the customer's 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.No adverse trends have been observed associated with the reported product and event.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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