FDA Adverse Event
Injury
Summary report: N
LASIK
MDR report key: 3231396
·
Received July 11, 2013
Report
- Report Number
- MW5030907
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- August 1, 2000
- Report Date
- July 11, 2013
- Product Code
- LZS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
LASIK SURGERY BOTH EYES IN 2000. STARTED WORSENING VISION IN 2005. NOW DIAGNOSED WITH ECTASIA, BOTH EYES, REQUIRING CORNEAL TRANSPLANT, MAY LEAD TO BLINDNESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321497 | LASIK | LASIK | LZS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |