AL-SCAN

Additional Manufacturer Narrative

DEVICE HAS NOT BEEN EVALUATED IN THIS CASE. HOWEVER, BASED ON THE INVESTIGATION INCLUDING INTERNAL TEST, THE NCO WAS ABLE TO DUPLICATE THE SIMILAR UNUSUAL AXIAL LENGTH AND WAVEFORMS BY ELECTRONIC DISCHARGE EXCEEDED THE CRITERIA. THE NCO CONSIDERED EXTERNAL ELECTROMAGNETIC DISTURBANCE IN ABNORMAL OPERATING CONDITIONS POSSIBLY MAY HAVE CAUSED TO AL-SCAN WHICH CONFORMS TO INTERNATIONAL STANDARDS FOR ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICE AND HAS BEEN VERIFIED TO OPERATE PROPERLY UNDER NORMAL OPERATING CONDITION. NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED IN THIS CASE. IN ORDER TO PREVENT THE INCIDENT IN CUSTOMER SITE IN THE UNITED STATES, NCO REQUESTED NIDEK INC. WHICH IS USA SUBSIDIARY OF NCO TO ALERT TO THIS SYMPTOM AND ALSO RECOMMENDED THAT THE SOFTWARE SHOULD BE UPGRADED WITH THE NEW VERSION. RECALL HAS BEEN INITIATED BY US UNDER RECALL REPORT NUMBER :2936921-7/01/2016-001-C.

Description of Event or Problem

THE MANUFACTURER, NIDEK CO., LTD.(ABBREVIATED: NCO) RECEIVED FOLLOWING INFORMATION FROM (B)(6). THE AL-SCAN MEASUREMENT DATA OF AXIAL LENGTH WITH THE RIGHT EYE IS 20.31MM, AND THE LEFT EYE IS 20.36MM. THE WAVEFORM LOOKED FINE, BUT DUE TO THE FACT THAT THE AXIAL LENGTH SHOWED SHORTER THAN AVERAGE, FELT UNCOMFORTABLE WITH THE RESULT, AND USED ULTRASOUND A-MODE TO MEASURE THE AXIAL LENGTH AGAIN. AS A RESULT, BOTH AXIAL LENGTHS WERE 22MM. THE DOCTOR AND STAFF DISCUSSED ABOUT THE MEASURED RESULT AND DECIDED TO USE THE RESULT OF ULTRASOUND A-MODE MEASUREMENT. NO FURTHER MALFUNCTION HAS BEEN REPORTED EVER SINCE THEN.