FDA Adverse Event
Malfunction
Summary report: N
SOFLEX SILICONE SQUARE EDGE FOLDABLE LENS
MDR report key: 3112127
·
Received July 14, 2006
Report
- Report Number
- 1920664-2006-00236
- Event Type
- Malfunction
- Date Received
- July 14, 2006
- Report Date
- June 14, 2006
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE HAPTIC OF THE LENS BENT IN THE DELIVERY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFLEX SILICONE SQUARE EDGE FOLDABLE LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |