MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR) manufactured by D.o.r.c. Dutch Ophthalmic Research Center (interna.
[179724016]
The device and log files will be returned to the manufacturer for investigation.
Patient Sequence No: 1, Text Type: N, H10
[179724017]
The surgeons reports that the aspiration-irrigation didn? T compensate well. It is an issue that is not present in all surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2020-00004 |
| MDR Report Key | 9591074 |
| Date Received | 2020-01-15 |
| Date Added to Maude | 2020-01-15 |
| 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, 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, 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 | 2020-01-15 |
| Device Availability | * |
| 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, 3214VN NL 3214 VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |