The phacoemulsification (phaco) handpiece was received and a visual assessment of the returned sample revealed discoloration on the aspiration port.The returned phaco handpiece was connected to a calibrated console.The phaco handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the phaco handpiece to meet product specifications.Testing found the phaco handpiece to functionally meet specifications.Therefore, the customer reported event was not able to be confirmed.Unrelated to the reported event, discoloration on the aspiration port was observed.However, how, or when the nonconformity occurred remains inconclusive.A phaco handpiece manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The phaco handpiece was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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