One opened phaco tip within a wrench in a bag for the report.The returned sample was visually inspected and was found to be nonconforming; it was bent at the cone to cannula transition.Wear was visible on the threads, back of flange and the nut corners, which is consistent with threading onto 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 exact root cause could not be determined from the investigation performed.The returned sample is visually non-conforming with the phaco tip bent; therefore, a bent phaco tip was confirmed; however, how and when the phaco tip became bent could not be determined.Most likely root cause is handling during placement of the phaco tip onto the handpiece.The exact root cause for the bent phaco tip 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.Any nonconformance, such as the phaco tip cannula bent exhibited on the returned opened sample, is removed from the lot and scrapped.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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