FDA Adverse Event
Injury
Summary report: N
LASIK
MDR report key: 2028363
·
Received March 20, 2011
Report
- Report Number
- MW5019888
- Event Type
- Injury
- Date Received
- March 20, 2011
- Date of Event
- May 28, 1999
- Report Date
- March 20, 2011
- Manufacturer
- LASIK
- Product Code
- LZS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD LASIK IN 1999 AND IN 2005, I HAD KERATOCONUS. I FEEL THAT I WAS NOT A GOOD CANDIDATE FOR THIS PROCEDURE. TO CORRECT THIS, I HAD TO UNDER GO A CORNEAL TRANSPLANT IN 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASIK | LASIK | LZS | LASIK | NONE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention |