FDA Adverse Event
Injury
Summary report: N
INTACS CORNEAL IMPLANTS
MDR report key: 2473785
·
Received March 15, 2012
Report
- Report Number
- 2953726-2012-00001
- Event Type
- Injury
- Date Received
- March 15, 2012
- Date of Event
- January 6, 2012
- Report Date
- February 28, 2012
- Manufacturer
- ADDITION TECHNOLOGY
- Product Code
- LQE
- PMA / PMN Number
- H040002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
INTACS WERE IMPLANTED INTO THE CORNEA BY USE OF THE INTRALASE LASER TECHNIQUE. AT POST-OP, CORNEAL EDEMA WAS EVIDENT SO INTACS WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTACS CORNEAL IMPLANTS | CORNEAL IMPLANTS | LQE | ADDITION TECHNOLOGY | ICI-450-150 | B11H1066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |