FDA Adverse Event
Malfunction
Summary report: N
LASIK
MDR report key: 2824612
·
Received November 2, 2012
Report
- Report Number
- MW5027516
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- November 1, 2007
- Report Date
- November 2, 2012
- Manufacturer
- NA
- Product Code
- LZS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I AM NOT SURE OF THE EXACT DATE OF MY LASIK SURGERY. I HAVE HAD MULTIPLE PROBLEMS ASSOCIATED WITH IT, INCLUDING SEVERE EYE PAIN, HEADACHES, INCREASED FLOATERS AND INABILITY TO FOCUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASIK | LASIK | LZS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |