MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR) 8000.COM02 manufactured by D.o.r.c. Dutch Ophthalmic Research Center (interna.
[179055494]
The incident could potentially have resulted in hypotony in the eye. The device and log files have been requested to be returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: N, H10
[179055495]
After the surgeon lifted his foot from the pedal, in silicone oil removal phase, the unit kept on aspiring. In addition the touchscreen of the monitor was blocked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2020-00002 |
| MDR Report Key | 9577839 |
| Date Received | 2020-01-10 |
| Date Added to Maude | 2020-01-10 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRIS FRYER |
| Manufacturer Street | SCHEIJDELVEQEG 2 |
| Manufacturer City | ZUILAND, NETHERLANDS 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal | 3214 VN |
| Manufacturer G1 | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA |
| Manufacturer Street | SCHEIJDELVEQEG 2 |
| Manufacturer City | ZUILAND, NETHERLANDS 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214 VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR) |
| Generic Name | PHACOEMULSIFICATION/VITRECTOMY SYSTEM |
| Product Code | HQE |
| Date Received | 2020-01-10 |
| Model Number | 8000.COM02 |
| Catalog Number | 8000.COM02 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA |
| Manufacturer Address | SCHEIJDELVEQEG 2 ZUILAND, NETHERLANDS 3214VN NL 3214 VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |