FDA Adverse Event
Malfunction
Summary report: N
TECNIS SYMFONY IOL
MDR report key: 6186246
·
Received December 13, 2016
Report
- Report Number
- MW5066780
- Event Type
- Malfunction
- Date Received
- December 13, 2016
- Date of Event
- December 12, 2016
- Report Date
- December 12, 2016
- Manufacturer
- ABBOTT MEDICAL OPTICS INC.
- Product Code
- HQL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ADVANCER PUSHED COMPLETELY THROUGH LENS IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 819918 | TECNIS SYMFONY IOL | IOL IMPLANT | HQL | ABBOTT MEDICAL OPTICS INC. | ZXR00U0250 | CB39356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |