One opened phacoemulsification (phaco) tip in a box was received.The phacoemulsification tip was visually inspected and deemed nonconforming, the phaco tip was broken across the air bypass (ab) hole with a jagged edge.The phaco tip had even wall thickness.There was wear on the threads, back of the flange and on the nut corners that was consistent with use.There was no occlusion observed in the inner diameter (id) of both pieces of the broken phaco tip returned.A functional flow check for occlusion was performed and deemed conforming.A good flow exiting the phaco tip was observed.A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirms the phaco tip was broken.The root cause for the broken phaco tip cannot be determined from this evaluation.The phaco tip visual inspection does not show any manufacturing issue that would cause the broken phaco tip.The complaint evaluation does not confirm the report of the phaco tip aspiration failure.The returned sample was found to be conforming for all visual and functional testing associated with the reported event of occlusion.No action was taken for the report of poor aspiration as the sample was functionally conforming.The exact root cause for the reported issue of broken or cracked phaco cannot be determined from this evaluation, therefore, no specific action with regard to this complaint was 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 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).
|