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 2016-06-27 for AL-SCAN manufactured by Nidek Co., Ltd..
[48258065]
Based on the investigation including internal test, the (b)(4) was able to duplicate the similar unusual axial length and waveforms by electronic discharge exceeded the criteria. The (b)(4) 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, (b)(4) requested nidek inc. Which is usa subsidiary of (b)(4) 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
[48258066]
The manufacturer, (b)(4) received following information from (b)(4) user through (b)(4) which is (b)(4) subsidiary of (b)(4). On (b)(6) 2016, axial lengths were measured before the operation of iols' implantation. The results of measurement was 20. 11mm/left eye before the operation. After the operation, the axial lengths were re-measured due to poor vision. The axial length after operation was 22. 83mm. When checking the data of the measurement results of (b)(4) facility, (b)(4) 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 | 3002807715-2016-00024 |
| MDR Report Key | 5752071 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-06-27 |
| Date of Report | 2016-06-24 |
| Date of Event | 2016-03-04 |
| Device Manufacturer Date | 2014-02-01 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AL-SCAN |
| Generic Name | OPTICAL BIOMETER |
| Product Code | HJB |
| Date Received | 2016-06-27 |
| 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 |