A physician reported that the phacoemulsification tip was broken during cataract surgery using the system when the surgeon was in the sculpting step making the groove, and at one point it was noticed that the tip was not eating and that it was pushing the nucleus.When it was removed from the eye, it was observed that the tip was broken in the sleeve.The tip was reused for this surgery.There was no patient injury.
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A sample was not received at the manufacturing site for evaluation; however, the attached customer photo confirms the reported issue of the doctor withdrew the tip and we noticed that it was broken.The broken portion of the tip was contained within the ultra-sleeve (pink).No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The report of phaco tip broken is confirmed based on the photo attached to parent complaint, however, because a sample was not received and no lot number was provided, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint 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 broken phaco tip exhibited on the photo attached to the parent complaint, 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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