FDA Adverse Event
Malfunction
Summary report: N
SPHERE
MDR report key: 9125330
·
Received September 26, 2019
Report
- Report Number
- 1627258-2018-00001
- Event Type
- Malfunction
- Date Received
- September 26, 2019
- Date of Event
- March 26, 2018
- Report Date
- October 11, 2018
- Manufacturer
- METRO OPTICS OF AUSTIN, INC. AUSTIN, TX
- Product Code
- HQD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
PATIENT COMPLAINED OF DISCOMFORT FROM LENS. DR. REPORTED BLEEDING IN THE EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 920676 | SPHERE | BOSTON XO STANDAD SPHERE LENS | HQD | METRO OPTICS OF AUSTIN, INC. AUSTIN, TX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |