Three opened trocar assemblies in a (small parts tray).Smpt within a tray were received, for the report of there was a leak on the valved trocars and the intra ocular pressure decreased.The returned samples were visually inspected and were found to be non-conforming with damaged and torn septum's.Leak testing could not be performed, due to the damage of the samples.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo attached to the parent complaint was reviewed, by the manufacturing site.The exact root cause for this complaint is unknown.The damaged condition of the valves could have contributed to the reported event.How and when, the valve became damaged cannot be determined, from the evaluation performed.The exact root cause for this complaint is unknown.Therefore, specific action for this complaint cannot be taken.An acceptance quality inspection is performed to ensure product meets release acceptance criteria.This inspection includes evaluation for damaged valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No adverse trends have been observed, associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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