A sample was not received at the manufacturing site for evaluation for the report of tip broken in patient¿s eye and removed; therefore, the condition of the product could not be verified.A photo of the pak label is attached to the parent file and has been reviewed by the investigation site.The product and lot information seen matches what was reported.A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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