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.
[48305070]
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 (b)(4). 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
[48305071]
The manufacturer, nidek co. , ltd(abbreviated: nco) received following information from (b)(6) user through nidek (b)(4) (abbreviated: (b)(4)) which is (b)(4) subsidiary of nco. On february 1st, 2016, axial lengths were measured before the operation of iols' implantation. Since the result of iol power was significantly unusual 32d, the eye clinic sent the patient to a large-scale hospital. The axial lengths were re-measured and the eyes were operated there. When checking the data of the measurement results of french 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
| Report Number | 3002807715-2016-00022 |
| MDR Report Key | 5752065 |
| Date Received | 2016-06-27 |
| Date of Report | 2016-06-24 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-04-15 |
| Date Added to Maude | 2016-06-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NORIYUKI YAMAGUCHI |
| Manufacturer Street | 34-14 HIROISHI |
| Manufacturer City | GAMAGORI, AICHI 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal | 443-0038 |
| Manufacturer Phone | 33678827 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AL-SCAN |
| Generic Name | OPTICAL BIOMETER |
| Product Code | HJB |
| Date Received | 2016-06-27 |
| Model Number | AL-SCAN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO., LTD |
| Manufacturer Address | 34-14 HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-27 |