MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-30 for AL-SCAN manufactured by Nidek Co., Ltd.
[118727277]
No detailed information from the distributor and hospital, and cause is unknown. However, a distributor's engineer checked the device with model eye on site and confirmed that the device worked properly and with no report on reoperation or medical intervention; therefore it is considered there is no risks of recurrence when the device is used adequately. Although this event occurred in a facility in colombia, this device is marketed in united state. Nidek determined that it is a reportable event as we became aware of that may have caused or contributed to a serious injury. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[118727278]
Based on the axial length measured with the nidek eye axial length measuring device (model: al - scan), the distributor notified us that visual acuity problems occurred in patients who underwent iol surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030392-2018-00006 |
| MDR Report Key | 7831688 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-30 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-08-03 |
| Device Manufacturer Date | 2018-06-27 |
| Date Added to Maude | 2018-08-30 |
| 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 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 | 2018-08-30 |
| 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 | 2018-08-30 |