There was no additional information provided.However, the handpiece was returned for evaluation.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The handpiece was received for evaluation.A visual assessment of the returned sample found no visual non-conformities.The handpiece was connected to a calibrated resistance breakout box, where the output and input impedances were found to be within specification.The returned sample was then connected to a calibrated system, where it passed tuning, and 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 failed to meet specifications.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpiece to fail to meet specifications.Disassembly of the handpiece revealed that the crystal stack was fused together, causing the observed failure mode.The root cause of the reported event can be attributed to the fusing of the crystal stack causing an electrical short circuit between the high and low electrodes.An internal investigation has been opened, to investigate this issue.An internal investigation has been opened, to investigate this issue.Alcon will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|