A phacoemulsification (phaco) tip sample was not received at the manufacturing site; therefore, the condition of the product could not be verified.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.A phaco tip sample was not received at the manufacturing site and the lot number indicates that the product was processed and released according to the product¿s acceptance 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 phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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