The lot complaint history was reviewed, this is the third complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.The customer provided an image showing applied pressure to the irrigation tubing by lifting the entire irrigations tubing upward toward the cassette resulting in a kink near the cassette.The laboratory was able to recreate the same kink by inducing the same pressure, when the tubing was released, the kink went away (the tubing should hang freely from the cassette).The customer should be reminded the directions for use stipulates good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.In returned condition, the wet tubing on the cassette did not exhibit any kinks and the irrigation tubing was measured and found to be conforming to specifications.A calibrated console was used to sample and the cassette primed and tuned with the ultrasonic handpiece successfully and could achieve maximum vacuum.No system message was generated, no fluid or air leaks, and no cracks were observed on the connectors that would have contributed to the reported event.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the balanced salt solution (bss) bottle to the irrigation and aspiration manifolds and continuously to the cassette housing.No occlusion or obstruction was observed during inspection and functional testing.The root cause of the customer's complaint could not be established as the returned cassette was evaluated and met 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.The manufacturer internal reference number is: (b)(4).
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