MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-06 for AL-SCAN manufactured by Nidek Co., Ltd.
[129574731]
Al-scan ((b)(4)) is currently under investigation. It is scheduled to be returned, and further investigation will be performed. Adverse event can be prevented by following the message "take model eye measurements. " appears on the device display prior to its use. It's also stated in the operator's manual (14101-p901-f7). Although this event occurred in a facility in (b)(6), this device is marketed in united states. Nidek determined that it is a reportable event as we became aware of that may have caused or contributed to a serious injury. The distributor reported that the incident (wrong average value calculation of axial length) occurred multiple times, and we are still confirming further details of this event. Follow up report will be submitted when we receive additional information. Al-scan is replaced at the facility, and no recurrence has been reported. In addition, no other facilities have reported same incident (wrong average value calculation of axial length).
Patient Sequence No: 1, Text Type: N, H10
[129574732]
An adverse event was reported while using al-scan ((b)(4)) which was installed two weeks ago. A physician implanted a wrong diopter iol into patient and reported that he was not satisfied with the result. There is no specific patient information or measurement data. The distributor reported that al-scan ((b)(4)) has been replaced. Al-scan measures axial length for six times, and calculates the average value. (each measured value and average value are displayed on the same screen. ) their service engineer performed a field investigation, and observed that average value indicates wrong calculation result as it is not the average value of six values of measurement result. The model eye's measured value should be 28. 00 mm, however; the average value measured by this device is sometimes 26. 44 mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030392-2018-00008 |
| MDR Report Key | 8140466 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2018-03-19 |
| Date Added to Maude | 2018-12-06 |
| 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. KATSUAKI TOHYAMA |
| Manufacturer Street | 34-14 MAEHAMA, HIROISHI-CHO |
| Manufacturer City | GAMAGORI, AICHI 4430038 |
| Manufacturer Country | JA |
| Manufacturer Postal | 4430038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AL-SCAN |
| Generic Name | OPTICAL BIOMETER |
| Product Code | HJO |
| Date Received | 2018-12-06 |
| Model Number | AL-SCAN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO., LTD |
| Manufacturer Address | 34-14 MAEHAMA, HIROISHI GAMAGORI, AICHI 4430038 JA 4430038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-06 |