AL-SCAN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-07-26 for AL-SCAN manufactured by Nidek Co., Ltd..

Event Text Entries

[50518152] 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. 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. Two patients were affected so two separate mdrs will be submitted for each event. Please refer to al-scan (b)(4) recall injury 3002807715-2016-00030, al-scan (b)(4) recall injury 3002807715-2016-00031.
Patient Sequence No: 1, Text Type: N, H10


[50518153] The manufacturer,nidek co. , ltd. (abbreviated: nco) received following information from an authorized distributor by nco in (b)(4). The axial length of 2 patients are measured 20. 6mm in each eye. Iol +32d and +33d were inserted for those patients as recommended according to the iol power formula. However, those patients got nearsighted by -9d after the surgery. Before the surgery, the quality of the scanning of al-scan were good with high signal to noise ratio. There were no corneal opacities and it was a standard cataract in a low hyperopia. After the surgery, the axial length was measured again and all four eyes resulted in 23. 3-23. 6mm. Both patients need iol replacement. No such issues have been occurred in the past except these two patients.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002807715-2016-00031
MDR Report Key5823563
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2016-07-26
Date of Report2015-08-17
Date of Event2015-08-17
Date Mfgr Received2015-08-17
Device Manufacturer Date2013-04-01
Date Added to Maude2016-07-26
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
Manufacturer G1NIDEK CO., LTD.
Manufacturer Street34-14 HIROISHI
Manufacturer CityGAMAGORI, AICHI 443-0038
Manufacturer CountryJA
Manufacturer Postal Code443-0038
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2936921-7/01/2016-001-C
Event Type3
Type of Report3

Device Details

Brand NameAL-SCAN
Generic NameOPTICAL BIOMETER
Product CodeHJB
Date Received2016-07-26
Model NumberAL-SCAN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
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 2016-07-26

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