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 used infusion manifold connected to the infusion cannula line was visually inspected and no obvious defects were detected.The sample was tested with the lab stock components using a constellation console.The sample could prime, tune with the ultrasonic handpiece and pass intraocular pressure calibration successfully.The snap clamp could be closed to stop fluid and opened to allow fluid flowing in several times without any issue.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.After 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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