The phacoemulsification handpiece was received, and a visual assessment of the returned sample revealed, no visual nonconformities.The returned phaco handpiece sample was connected to a calibrated ophthalmic vision system.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.A phacoemulsification 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.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.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 is inconclusive.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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