FDA Adverse Event
Injury
Summary report: N
CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)
MDR report key: 5795396
·
Received July 14, 2016
Report
- Report Number
- 3009108089-2016-00002
- Event Type
- Injury
- Date Received
- July 14, 2016
- Report Date
- June 15, 2016
- Manufacturer
- COOPERVISION CL KFT
- Product Code
- LPL
- PMA / PMN Number
- K130331
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS CANNOT BE PERFORMED. NO LENSES WERE RETURNED FOR EVALUATION. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE EVENT IS UNCONFIRMED.
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER THAT A CONSUMER SOUGHT MEDICAL TREATMENT AND WAS DIAGNOSED WITH VIRAL KERATITIS. A VIRUS WAS FOUND IN THE SOLUTION, AND THE CONSUMER EXPERIENCED VISION LOSS (REDUCTION) IN ONE EYE. A REASONABLE AND GOOD FAITH EFFORT WAS MADE TO ESTABLISH COMMUNICATION AND TO OBTAIN MEDICAL DOCUMENTATION WITHOUT RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448142 | CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) | CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) | LPL | COOPERVISION CL KFT | U0027373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |