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.Two red translucent 0.9 millimeter infusion sleeves were visually inspected.Using lab stock phaco tip, the infusion sleeves were able to be attached on the handpiece without twisting on the tip.The sleeves matched the color requirements.The returned sample met specifications.The root cause of the customer's complaint could not be established.The returned sample met specifications.No contributing factors could be identified, that could cause the customer¿s experience.After the investigation of this complaint, it has been determined, that this sample met specifications.Quality assurance will continue to monitor customer complaints via the complaint review meetings.And will take action for any future occurrences, as is deemed necessary.The manufacturer internal reference number is: (b)(4).
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