FDA Adverse Event
Injury
Summary report: N
SILICONE ADVANCED OPTIC LENS
MDR report key: 1013793
·
Received March 14, 2008
Report
- Report Number
- 1920664-2008-00389
- Event Type
- Injury
- Date Received
- March 14, 2008
- Date of Event
- February 25, 2008
- Report Date
- February 25, 2008
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P910061
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SEE MDR 1920664-2008-00390 FOR THE DELIVERY DEVICE USED WITH THIS INTRAOCULAR LENS. RESULTS: ONE HAPTIC OF LENS WAS FOUND BENT, THE INSERTER WAS NOT RETURNED.
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 | SILICONE ADVANCED OPTIC LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |