Nidek field service engineer (fse) went to the field for device evaluation on (b)(6) 2018.The device was tested and evaluated by the fse.Customer complaint for intense flashback during laser firing on the device gyc-500d serial number: (b)(4) could not be duplicated.Fse powered on the system and found in working order.Tested energies at 100 mw, 200 mw and 500 mw and all are proper.Fse removed the oculars and tested 532 nm filter for any flashback but could still not duplicate any flash back.Checked 532 nm filter for any cracks or scratches and found everything was proper.Tested function of filter all proper.Reseated microscope oculars and test fire on orange paper for proper alignment and spot size.No problem found during device evaluation as the flashback and low energies were inconclusive.Thereby, nidek inc.Determined that the customer's complaint issue was inconclusive.The use of universal mirror lens ( volk hr wide field) could have caused flash/reflection that could have been interpreted as flashback by the doctor.If additional significant information is available at a later date, a follow-up report will be submitted.Nidek inc.Considers flashback issue a reportable event as the device has malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur.
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