A review of the device history record was traceable to the reported serial number indicating that the product was processed and released according to the product¿s acceptance criteria.A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to the day of treatment.Logfile review for the several treatment days was performed.Review of the logfile for one day of treatment showed no error messages or warnings.During the start-up in the morning, the system passed all initialization steps without any relevant deviation.The user performed the gas change, performed the scanner test and performed the necessary energy and eyetracker test without any issue.The fluence test was performed several times and with different energy values.After the seventh time, the fluence test was passed successfully.The related treatment cannot be identified.The review of the complete day showed no abnormalities or deviations.The user performed energy checks before each patient.The eyetracker was activated during the complete day.Review of the logfiles for another day of treatment showed no error messages or warnings.During the start-up in the morning, the system passed all initialization steps without any relevant deviation.The user performed the gas change, performed the scanner test and performed the necessary energy and eyetracker test without any issue.The fluence test was performed several times and with different energy values.After the fourth time, the fluence test was passed successfully.The related treatment cannot be identified.The review of the complete day showed no abnormalities or deviations.The logfiles showed several successfully performed treatments.The user performed energy checks before each patient.The eyetracker was activated during the complete day.Review of the logfile for another day of treatment showed no error messages or warnings.During the start-up in the morning, the system passed all initialization steps without any relevant deviation.The user performed the gas change, skipped the scanner test and performed the necessary energy, fluence and eyetracker test without any issue.The related treatment cannot be identified.The review of the complete day showed no abnormalities or deviations.The logfile showed several successfully performed treatments.The user performed energy checks before each patient.The eyetracker was activated during the complete day.According logfile review, no technical root cause was identified as the product was found to be within specifications.The manufacturer internal reference number is: (b)(4).
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