FDA Adverse Event
Malfunction
Summary report: N
SILICONE ADVANCED OPTIC-VIOLET SHIELD
MDR report key: 1180802
·
Received September 23, 2008
Report
- Report Number
- 1920664-2008-00994
- Event Type
- Malfunction
- Date Received
- September 23, 2008
- Date of Event
- August 28, 2008
- Report Date
- August 28, 2008
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P910061
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE HAPTIC WAS TORN DURING THE INSERTION OF THE LENS INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED WITH NO INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ADVANCED OPTIC-VIOLET SHIELD | INTRAOCULAR LENS | HQL | BAUSCH & LOMB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |