One opened phacoemulsification tip in a wrench, in a blister, was received for the report.The phacoemulsification tip was visually inspected and found conforming.The threads were functionally checked with a thread gage and the threads were found 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 photo attached to the parent file was reviewed by the manufacturing site.The photo shows a blister pack with reported lot number.Reported issue cannot be confirmed from photo.The returned sample was found to be conforming for all visual and functional testing associated with the reported event; therefore, a phacoemulsification tip cannot be tightened tightly was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the phacoemulsification tip was manufactured to specifications.All phacoemulsification 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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