MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-29 for AL-SCAN manufactured by Nidek Co. Ltd..
[126534798]
Evaluation of the device and investigation of the issue is on-going. A follow-up report will be submitted once evaluation of the device is fully completed. (b)(4) determined that this is a reportable event as we became aware of a malfunction that may have caused or contributed to a serious injury. See attached customer communication emails as well as parameter measurements for references.
Patient Sequence No: 1, Text Type: N, H10
[126534799]
(b)(4) received an e-mail notification on (b)(6) 2018 addressed to the territory sales manager that the customer (doctor) had performed three lens exchanges owing to the significantly wrong lens calculations made by the al-scan device serial (b)(4). However, it was later confirmed by the customer that there were only two lens exchanges performed. The patients had complained of very poor visual acuity post operatively following the initial procedures. The type of iol used was sn60wf manufactured by alcon. In addition, on (b)(6) 2018 the customer added experiencing issues with auto focus function and the k reading not showing up on the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2018-00010 |
| MDR Report Key | 8015938 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-29 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2014-08-21 |
| Date Added to Maude | 2018-10-29 |
| 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. TOSHIO MURATA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| Manufacturer Phone | 5103537785 |
| Manufacturer G1 | NIDEK CO. LTD. |
| Manufacturer Street | 34-14 HIROSHI |
| Manufacturer City | GAMAGORI, AICHI 4430038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 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 | 2018-10-29 |
| Returned To Mfg | 2018-10-15 |
| Model Number | AL-SCAN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO. LTD. |
| Manufacturer Address | 34-14 HIROSHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-29 |