A review of the device history records traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.One opened phacoemulsification tip in a pouch was received for the report of a piece of metal threading from the balanced tip broke off.The phacoemulsification tip was visually inspected and deemed nonconforming, the phacoemulsification tip was broken at the thread area, the break was jagged.There was wear on threads, flange and nut.The foreign material was sent to the lab for particle analysis.Analysis found the foreign material with an elemental composition identified as carbon, oxygen, aluminum and titanium which matches with the balanced tip composition.Four photos attached to the parent complaint were reviewed by the investigation site.Photo 1 shows a phacoemulsification tip with what appears to be a piece of foreign material.Photo 2 shows a magnified version of the foreign material.Photos 3 and 4 shows a pak label, the product and lot number were confirmed.The evaluation confirms the foreign material and broken thread reported by the customer.The particle analysis found the foreign material to contain titanium.Phacoemulsification tips are made from titanium.How and when the phacoemulsification tip's thread became broken and the metal entered the eye cannot be determined from this evaluation and a root cause cannot be determined for the complaint as described by the customer.A potential contributing factor is handling during surgery.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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