One opened phaco tip in a wrench, in a box with tyvek label, was received for the report.The phaco tip was visually inspected and found conforming.The threads were functionally checked, and the threads were deemed to be conforming.There was wear on the back of the flange, thread area and nut corners consistent with threading on a handpiece.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 complaint evaluation could not confirm the reported complaint, the phaco tip was visually conforming and the thread check was performed and was also found to be conforming.The root cause cannot be determined from this evaluation as the threads were conforming.No action was taken as the phaco tip was manufactured to specifications.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 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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