FDA Adverse Event
Injury
Summary report: N
LASIK
MDR report key: 4121835
·
Received September 22, 2014
Report
- Report Number
- MW5038342
- Event Type
- Injury
- Date Received
- September 22, 2014
- Date of Event
- April 6, 2007
- Report Date
- September 22, 2014
- Product Code
- LZS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
HAD LASIK SURGERY IN 2007 AND IT TOOK MY EYES A LONG TIME TO HEAL, AND WERE EXCESSIVELY DRY. I WAS IMMEDIATELY IMPAIRED FROM DRIVING AT NIGHT OR IN FOG, OR SEVERE PAIN OR CLOUDY TIMES. IN THE DARK I AM COMPLETELY BLIND AS TO WHAT AND WHERE CAN SEE AND DRIVING I AM COMPLETELY IN A GLARE FOREVER. IT WAS SUGGESTED BY THE DR TO WEAR SUNGLASSES AT NIGHT BUT THAT DOESN'T HELP. HAD I BEEN TOLD AND COMPLETELY UNDERSTOOD AT A YOUNG AGE OF (B)(6) I WOULD NEVER BE ABLE TO DRIVE AT NIGHT I WOULDN'T HAVE DONE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 587533 | LASIK | NONE | LZS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Disability |