MAUDE MDR 8776830
- MDR report key
- 8776830
- Report number
- 2028159-2019-01263
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-04-30
- Date received
- 2019-07-10
- 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
- MS. CINDY MILAM
- Address
- 6201 SOUTH FREEWAY MAIL STOP AB2-6 FORT WORTH TX 76134 US
- Phone
- 817-817-8176
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ORA SYSTEM WITH VERIFEYE MESSAGING | ABERROMETER, OPHTHALMIC | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER | NCF | NA | 8065998329 | NA | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-07-10 | 0 | 1. O |
Event Narratives#
No narrative records found.