FDA Adverse Event
Malfunction
Summary report: N
LIQUID OPTICS INTERFACE
MDR report key: 7246979
·
Received February 7, 2018
Report
- Report Number
- 7246979
- Event Type
- Malfunction
- Date Received
- February 7, 2018
- Date of Event
- September 28, 2017
- Report Date
- January 3, 2018
- Manufacturer
- OPTIMEDICA CORPORATION
- Product Code
- OOE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
UNABLE TO "DOCK" PATIENT DUE TO LOSS OF SUCTION. ANOTHER LOI OF THE SAME SIZE WAS OPENED & IT WORKED NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 92045 | LIQUID OPTICS INTERFACE | OPHTHALMIC FEMTOSECOND LASER | OOE | OPTIMEDICA CORPORATION | 3269146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |