FDA Adverse Event
Injury
Summary report: N
EASY LOAD INSERTER
MDR report key: 1013794
·
Received March 14, 2008
Report
- Report Number
- 1920664-2008-00392
- Event Type
- Injury
- Date Received
- March 14, 2008
- Date of Event
- February 25, 2008
- Report Date
- February 25, 2008
- Manufacturer
- BAUSCH & LOMB
- Product Code
- MSS
- PMA / PMN Number
- K970727
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SEE MDR 1920664-2008-00391 FOR THE INTRAOCULAR LENS USED WITH THIS DELIVERY DEVICE.
Description of Event or Problem · 1
THE HAPTIC CAME OUT THE SIDE OF THE INSERTER DURING THE INSERTION OF THE LENS INTO THE PATIENT'S EYE. ANOTHER LENS WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASY LOAD INSERTER | INTRAOCULAR LENS DELIVERY DEVICE | MSS | BAUSCH & LOMB | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |