The phacoemulsification (phaco) handpiece (hp) was received and a visual assessment of the returned sample found no visual nonconformities.The returned phaco handpiece was connected to a calibrated system.The phaco handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.During the burn-in test, the temperature of the hp was measured and was found to be within product specifications.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpiece to meet product specifications.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The phaco handpiece was found to meet product specifications; therefore, the root cause of the reported event cannot be determined conclusively.The company service representative examined the system was not able to confirm or replicate the reported event.The system was then tested and met all product specifications.The manufacturer internal reference number is: (b)(4).
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