One opened broken phacoemulsification (phaco) tip without a wrench in a plastic container with a lid and within a tray was received.The phaco tip was visually inspected and deemed nonconforming, the phaco tip was broken at the aspiration bypass (ab) hole with a very jagged edge.The phaco tip had even wall thickness.There was wear on the threads, back of flange and nut corners that was 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 complaint was reviewed by the manufacturing site.The photo is of a broken phaco tip in a tray, the reported product complaint is confirmed.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.A complaint trend has been identified for broken phaco therefore an investigation has been opened.The exact root cause for the phaco tip was broken during surgery is unknown; therefore, specific action with regards to this complaint cannot be taken.An investigation is currently in progress, in order to further investigate issues with the phaco tip.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the broken phaco tip 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.The manufacturer internal reference number is: (b)(4).
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