MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-08-17 for OPD-SCAN III N/A manufactured by Nidek Co. Ltd..
[117577256]
Nidek inc. Considers this a reportable event, however device malfunction is yet to be determined. At this time, nidek has no additional information of patient condition and evaluation on the device has not begun, a supplemental follow-up report will be submitted once the device evaluation and repair are completed.
Patient Sequence No: 1, Text Type: N, H10
[117577257]
On august 3, 2018, nidek inc. Senior ra/qa manager received an email from our distributor (b)(4) director of customer care regarding a complaint they received on june 22, 2018 from their customer, (b)(6). A patient ((b)(6)) at (b)(6) had an eye exam, and experienced a very bright flash from opd and felt like there was a reaction and her (optical) nerves or something may have been affected. (b)(6) complained that no one warned her about the light and that she told them not to take any pictures including opd ct images, so the images were not permitted by her. The doctor performing the procedure, however, explained the entire procedure including the technology and the software to be used and affirmed that they were safe for use. However, the patient was very upset and claimed that the doctor was defending the equipment despite acknowledging having understood and receiving all the information prior to the examination. The patient added that she was experiencing symptoms of eyestrain, sensitivity to light and anxiety. The patient has gone to her vision plan to complain, but was told nothing was done wrong.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2018-00009 |
| MDR Report Key | 7793853 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-17 |
| Date of Report | 2019-02-19 |
| Date of Event | 2018-06-18 |
| Date Mfgr Received | 2018-08-03 |
| Date Added to Maude | 2018-08-17 |
| 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 HIROISHI |
| Manufacturer City | GAMAGORI, AICHI 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPD-SCAN III |
| Generic Name | OPD-SCAN III REFRACTIVE POWER/CORNEAL ANALYZER |
| Product Code | HKO |
| Date Received | 2018-08-17 |
| Model Number | OPD-SCAN III |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-08-17 |