N
Patient 1
MAUDE MDR 8465466
- MDR report key
- 8465466
- Report number
- 9615010-2019-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-02-27
- Date received
- 2019-03-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. VERNON BROWN
- Address
- 5160 HACIENDA DRIVE DUBLIN CA 94568 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OPMI LUMERA T | OPMI LUMERA T | CARL ZEISS MEDITEC AG (OBERKOCHEN) | HRM | N/A | 302608-9011-000 | NA | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-29 | 0 |
Event Narratives#
D
Patient 1
DURING INSPECTION OF THE DEVICE, A CZMI FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE OPMI LUMERA T HAD A LIGHT MODULE INSTALLED WHICH IS NOT INTENDED FOR OPHTHALMIC SURGERIES.