FDA Adverse Event
Malfunction
Summary report: N
POSTERIOR CHAMBER INTRAOCULAR LENS
MDR report key: 1231015
·
Received October 28, 2008
Report
- Report Number
- 1920664-2008-01109
- Event Type
- Malfunction
- Date Received
- October 28, 2008
- Date of Event
- October 2, 2008
- Report Date
- October 2, 2008
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P840039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULTS - THE EVALUATION OF THE LENS CONFIRMED THE COMPLAINT.
Description of Event or Problem · 1
A DING ON THE LENS WAS NOTICED AFTER IT WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED WITHOUT ENLARGEMENT OF THE INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSTERIOR CHAMBER INTRAOCULAR LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |