FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 2050286
·
Received April 6, 2011
Report
- Report Number
- MW5020199
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- February 6, 2010
- Report Date
- April 6, 2011
- Manufacturer
- UNK
- Product Code
- LZS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- ME, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I WAS DIAGNOSED WITH KERATOCONUS AND DEEMED TO NOT BE A CANDIDATE FOR LASIK. SEVERAL MONTHS LATER I WENT TO THE SAME OFFICE TO INQUIRE ABOUT PRK. THEY TESTED AND DECIDED I WAS A CANDIDATE FOR LASIK. I HAD THE SURGERY DONE IN THE RIGHT EYE. MY VISION NOW IS BY FAR WORSE THAN IT WAS INITIALLY. THEY ARE NOW TALKING ABOUT CORNEA TRANSPLANT. I WON'T GO BACK TO THEM. F/U AND FITTED FOR CONTACT LENS. LENS WILL NOT STAY IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | LASIK | LZS | UNK | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other| R| S |