FDA Adverse Event
Other
Summary report: N
OASYS
MDR report key: 1352030
·
Received March 27, 2009
Report
- Report Number
- MW5010495
- Event Type
- Other
- Date Received
- March 27, 2009
- Report Date
- January 16, 2009
- Product Code
- LPL
- Report Source
- Voluntary report
Narratives
Description of Event or Problem · 1
I AM AN OD. I HAVE BEEN SEEING A LARGE NUMBER OF EKC CASES AND IN 2008; I SAW A TOTAL PTS. WHEN I LOOKED AT WHAT SEEMED TO BE THE SAME WITH ALL OF THESE, I NOTICED THAT AROUND 80% WERE PATIENTS THAT WERE WEARING AV LENSES, EITHER OASYS OR ADVANCE AND ALSO USING OPTIFREE REPLENISH. I WASN'T SURE IF THESE NUMBERS WERE SIGNIFICANT, BUT I FEEL AS THOUGH I HAVE A DUTY TO REPORT THIS AS IT SEEMS ALMOST MORE THAN A COINCIDENCE THAT THESE ARE NOT RELATED TO A CONTACT LENS/SOLUTION ASSOCIATION. I WOULD BE GRATEFUL FOR ANY INPUT OR GUIDANCE YOU MAY BE ABLE TO GIVE ME. THANK YOU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OASYS | NONE | LPL | ||||
| 2 | ADVANCE | NONE | LPL | ||||
| 3 | OPTIFREE REPLENISH | NONE | LPN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |