Additional information was added to d9, h3, h4, h6 and h10.H4: device manufactured between september 29, 2021to september 30, 2021.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A magnified visual inspection was also performed, and no foreign matter was observed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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