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..
[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
| Report Number | 3002807715-2016-00031 |
| MDR Report Key | 5823563 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-07-26 |
| Date of Report | 2015-08-17 |
| Date of Event | 2015-08-17 |
| Date Mfgr Received | 2015-08-17 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2016-07-26 |
| 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 |
| Manufacturer G1 | NIDEK CO., LTD. |
| Manufacturer Street | 34-14 HIROISHI |
| Manufacturer City | GAMAGORI, AICHI 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2936921-7/01/2016-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AL-SCAN |
| Generic Name | OPTICAL BIOMETER |
| Product Code | HJB |
| Date Received | 2016-07-26 |
| Model Number | AL-SCAN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-07-26 |