MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for YC-1800 manufactured by Nidek Co. Ltd.
[105520108]
The ophthalmologist observed pitting on the posterior surface of the lens while performing surgery. However, the ophthalmologist completed the surgical procedure by performing certain modifications to achieve the intended results. Nidek inc. Has learned that dr. (b)(6) has doubts the effectiveness/reliability of the device in question and therefore, nidek has decided to replace it with a new yc-1800. The device is not yet evaluated by nidek inc. A follow-up report to this mdr will be submitted upon the completion of device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[105520109]
On (b)(6) 2018, the customer contacted nidek inc. Field service manager who later communicated to nidek inc. Customer service manager to report that the doctor observed pitting lens during surgical procedure. A total of 3 incidents were reported and a separate mdr will be submitted for each case. Two patients have acrysoft sn60wf monofocal lens and one have multifocal lens. There was no serious adverse event reported from the user facility but nidek inc. Considers pitting lens issue on yc-1800 a reportable event as it is an undesirable condition and has a potential to cause or contribute to a serious injury if the issue were to recur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2018-00004 |
| MDR Report Key | 7419968 |
| Date Received | 2018-04-10 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-08-02 |
| Date Added to Maude | 2018-04-10 |
| 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 | 5103537718 |
| Manufacturer G1 | NIDEK CO. LTD |
| Manufacturer Street | 34-14 HIROSHI |
| 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 | 0 |
| Brand Name | YC-1800 |
| Generic Name | YAG LASER |
| Product Code | LXS |
| Date Received | 2018-04-10 |
| Model Number | YC-1800 |
| 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 | 1. Life Threatening; 2. Deathisabilit | 2018-04-10 |