FDA Adverse Event
Injury
Summary report: N
ILASIK
MDR report key: 3960720
·
Received July 22, 2014
Report
- Report Number
- MW5037415
- Event Type
- Injury
- Date Received
- July 22, 2014
- Date of Event
- July 18, 2014
- Report Date
- July 21, 2014
- Product Code
- LZS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
UNDERWENT LASIK SURGERY; RESULTED IN DIFFUSE LAMELLAR KERATITIS AND HAZY VISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427085 | ILASIK | ILASIK | LZS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |