Evaluation summary: the lot specific to this event is not known; therefore, lot history and dhr reviews were not possible.The customer did not retain a sample for this complaint report; functional testing could not be conducted.The system vision system operator's manual provides the following in regard to loss of aspiration/suction issues: insufficient aspiration probable cause: 1.Loose blue luer fittings, 2.Damaged o-ring (ultraflow irrigation/aspiration handpiece only), 3.Clogged tip, 4.Kinked or damaged tubing, 5.Cracked blue fitting.Recommended solutions: 1.Reconnect securely, 2.Inspect o-ring and replace, as necessary, 3.Flush tip with sterile water or bss sterile irrigation solution.Retest.Replace tip.Retest, 4.Check tubing and/or replace fluidics module system (fms), 5.Check fitting and/or replace fms.The root cause of the customer's complaint could not be determined as a sample was not returned.Additional information has been requested but not received to date.(b)(4).
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