FDA Adverse Event
Other
Summary report: N
PROCLEAR MULTIFOCAL
MDR report key: 3131144
·
Received May 23, 2013
Report
- Report Number
- 9614392-2013-00028
- 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 LEFT EYE. SYMPTOMS APPEARED TO HAVE DEVELOPED AFTER FIRST USE OF THE CONTACT LENS. PT TREATED 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 ID MOSTLY RESOLVES. PT PERMANENTLY DISCONTINUED CONTACT LENS WEAR (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228843 | PROCLEAR MULTIFOCAL | LPL, SOFT CONTACT LENS, DAILY WEAR | LPL | COOPERVISION MANUFACTURING, LTD. | 5029052812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other| R |