MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-09-14 for EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR) 8000.COM05 N/A manufactured by Dutch Ophthalmic Research Center.
[86244374]
Any additional information received will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[86244375]
During surgery, the screen froze and therefore the eva was turned off and on. In the meantime, the eye turned to hypotonic. The patient got a hypotonic eye. The surgeon intervened manually. According to (b)(4) product specialist, the surgeon had to stabilize the eye and its pressure before rebooting the eva, this would have prevented the hypotonic eye. The frozen screen will be investigated once the screen is replaced and returned for investigation. Any further information will be reported in a supplemental report. Please note that this incident occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[117916115]
The affected screen has been received and the investigation has started. The results of the investigation will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222074-2017-00010 |
| MDR Report Key | 6866886 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-09-14 |
| Date of Report | 2018-08-23 |
| Date of Event | 2017-08-08 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2016-11-09 |
| Date Added to Maude | 2017-09-14 |
| 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 | MS. ANNELIES POTH |
| Manufacturer Street | SCHEIJDELVEQEG 2 BUILDING 1 |
| Manufacturer City | ZUILAND, NETHERLANDS NH 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal | 3214 VN |
| Manufacturer Phone | 6037786929 |
| Manufacturer G1 | DUTCH OPHTHALMIC RESEARCH CENTER |
| Manufacturer Street | SCHEIJDELVEWEG 2 3214 VN |
| Manufacturer City | ZUIDLAND, 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 | MLZ |
| Date Received | 2017-09-14 |
| Returned To Mfg | 2017-11-23 |
| Model Number | 8000.COM05 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUTCH OPHTHALMIC RESEARCH CENTER |
| Manufacturer Address | SCHEIJDELVEWEG 2 3214 VN ZUIDLAND, 3214VN NL 3214 VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-09-14 |