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 2019-05-16 for YC-1800 manufactured by Nidek Co. Ltd..
[146485974]
The customer device yc-1800 #y1620029 was recently repaired by nidek inc. On 4/12/2019. The doctor performed 10 procedures (b)(6) 2019, but observed 2 incidents of pitting lens. The doctor is currently operating loaner device # y1620097 and has no problem with the device functionality. At this time, evaluation on the yag laser is on-going; a supplemental follow-up report will be submitted once the device evaluation and repair are completed.
Patient Sequence No: 1, Text Type: N, H10
[146485975]
Nidek inc. Sales manager received a telephone call from the customer on (b)(6) 2019 to report that their yag laser yc-1800 was malfunctioning. The doctor was noticing pitting lens and was having trouble focusing. Nidek inc. Service manager spoke to the customer on (b)(6) 2019. Based on doctor's remarks, the aiming beam to yag laser beam alignment was off; the yag laser beam focuses 120? M anterior with respect to the aiming beam. The surgeries were complete eventually by setting the yag laser with 250? M focus shift posteriorly at energy 1. 4 mj. There were two cases of pitting lens reported, thereby, two individual reports will be submitted. This report is submitted for a male patient with multi focal type iol on the left eye. However, there was no patient injury reported. Nidek inc. Considers pitting lens issue 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 | 0002936921-2019-00007 |
| MDR Report Key | 8618016 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-16 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-04-19 |
| Date Mfgr Received | 2019-04-19 |
| Device Manufacturer Date | 2016-12-09 |
| Date Added to Maude | 2019-05-16 |
| 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. TODD MILHOLLAND |
| Manufacturer Street | 2040 CORPORATE COURT |
| Manufacturer City | SAN JOSE CA 951317474 |
| Manufacturer Country | US |
| Manufacturer Postal | 951317474 |
| Manufacturer Phone | 5103537702 |
| 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 | 3 |
| Brand Name | YC-1800 |
| Generic Name | YAG LASER |
| Product Code | LXS |
| Date Received | 2019-05-16 |
| Returned To Mfg | 2019-04-29 |
| Model Number | YC-1800 |
| 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 | 2019-05-16 |