FDA Adverse Event
Other
Summary report: N
FREQUENTLY MULTIFOCAL
MDR report key: 3131143
·
Received May 23, 2013
Report
- Report Number
- 9614392-2013-00029
- Event Type
- Other
- Date Received
- May 23, 2013
- Date of Event
- February 15, 2013
- Report Date
- April 24, 2013
- Manufacturer
- COOPERVISION MANUFACTURING, LTD.
- Product Code
- LPL
- PMA / PMN Number
- K112302
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
COOPERVISION WAS MADE AWARE OF A PT THAT DEVELOPED A CENTRAL CORNEAL SCAR IN THE RIGHT EYE. SYMPTOMS APPEARED TO HAVE DEVELOPED AFTER FIRST USE OF THE CONTACT LENS. PT TREATS WITH A TOPICAL ANTI-INFECTIVE AND CORTICOSTEROID COMBINATION. CORNEAL SPECIALIST THAT WAS INVOLVED STATED THAT THE OPACITIES MAY HAVE BEEN MIGRATING EPITHELIAL STEM CELLS FROM LONG TERM CONTACT LENS WEAR. THERE MAY HAVE BEEN A SCLERITIS COMPONENT TO THIS TOO. PT CONDITION IS MOSTLY RESOLVED. PT PERMANENTLY DISCONTINUED CONTACT LENS WEAR (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229734 | FREQUENTLY MULTIFOCAL | LPL, SOFT CONTACT LENS, DAILY WEAR | LPL | COOPERVISION MANUFACTURING, LTD. | 5025553714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other| R |