AL-SCAN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-27 for AL-SCAN manufactured by Nidek Co., Ltd.

Event Text Entries

[48306909] 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. 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.
Patient Sequence No: 1, Text Type: N, H10


[48306910] The manufacturer, nidek co. , ltd (abbreviated: nco). Received following information from (b)(6) user through nidek (b)(4) which is (b)(4) subsidiary of nco. On (b)(6) 2016, axial lengths were measured before the operation of iols' implantation. The results of measurement were 22. 69mm/right eye and 21. 43mm/left eye before the operation. We have not received post-operation data yet. However, we determined from the waveforms that the unusual symptom occurred there. When checking the data of the measurement results of (b)(4) facility, nco confirmed the measurement result of unusual axial length and waveforms at the right end portion of them.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002807715-2016-00025
MDR Report Key5752138
Date Received2016-06-27
Date of Report2016-06-24
Date of Event2016-03-04
Date Mfgr Received2016-05-03
Device Manufacturer Date2014-02-01
Date Added to Maude2016-06-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. NORIYUKI YAMAGUCHI
Manufacturer Street34-14 HIROISHI
Manufacturer CityGAMAGORI, AICHI 443-0038
Manufacturer CountryJA
Manufacturer Postal443-0038
Manufacturer Phone33678827
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAL-SCAN
Generic NameOPTICAL BIOMETER
Product CodeHJB
Date Received2016-06-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNIDEK CO., LTD
Manufacturer Address34-14 HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-06-27

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