MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,oth report with the FDA on 2015-07-07 for YC-1800 manufactured by Nidek Co., Ltd..
[23665516]
The affected device has not been returned to nidek. The inspection has not done yet so the results of evaluation are not available. Nidek customer service manager contacted customer to gather additional information. Doctor confirmed that in total five patients had pitting in the lens over the period of 6 months. Dates of surgery have not been provided. However doctor provided patient information and confirmed that none of the patients hand any kind of adverse events and no medical and surgical treatment was required for pitting. Nidek asked customer to send the device back to nidek for evaluation. The device will be evaluated by the nidek service engineer. Should new information that changes the facts and/or conclusion of this report become available, a supplemental report will be submitted. Nidek considers this failure mode a reportable event as the device has malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur. Additional four mdrs will be submitted for additional four patients.
Patient Sequence No: 1, Text Type: N, H10
[23665517]
Nidek inc. Received a complaint from a customer on (b)(6) 2015. Doctor reported that he had received the nidek inc. Yc-1800 recall notification letter. Doctor also reported that he had noticed pitting lens in 5 of his patients. Doctor mentioned that it was just small pitting and none of the patients had any adverse events and no medical or surgical intervention was required for this issue.
Patient Sequence No: 1, Text Type: D, B5
[30584629]
The device was returned back to nidek on 9/23/2015. The device was evaluated by nidek service engineer (se) on 10/22/2015. The device was tested and inspected for proper function. The laser energy output was tested and verified. Focus and alignment of yag/ aiming beam was check and verified. No failure was found. The se confirmed that the device operated within specifications. However, as per customer's request the device was exchanged with another yc-1800 sn: (b)(4) by nidek.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00031 |
| MDR Report Key | 4905208 |
| Report Source | 05,06,HEALTH PROFESSIONAL,OTH |
| Date Received | 2015-07-07 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-10-22 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-07-31 |
| 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 | NEO YAMAGUCHI |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| Manufacturer Phone | 5103537785 |
| Manufacturer G1 | NIDEK CO., LTD. |
| Manufacturer Street | 34-14, HIROISHI, GAMAGORI |
| Manufacturer City | AICHI 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2936921-2/20/2015-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YC-1800 |
| Generic Name | ND: LASER |
| Product Code | LXS |
| Date Received | 2015-07-07 |
| Returned To Mfg | 2015-09-23 |
| 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, HIROISHI, GAMAGORI AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-07 |