A technician reported eye tracker problem, difficulty locking on to pupil.Reporter indicated all procedures were completed; however, it was with extended time periods.No patient harm reported.Upon additional follow up, reporter indicated that it did not take longer than one minute to get the tracker to work.
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Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The device history records (dhr) for the device were reviewed.The associated device was released based on company acceptance criteria.(b)(4).
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