FDA Adverse Event
Injury
Summary report: N
KAMRA
MDR report key: 5247095
·
Received November 24, 2015
Report
- Report Number
- 3008401069-2015-00010
- Event Type
- Injury
- Date Received
- November 24, 2015
- Date of Event
- July 30, 2015
- Report Date
- April 22, 2016
- Manufacturer
- ACUFOCUS, INC.
- Product Code
- LQE
- PMA / PMN Number
- P120023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): DEVICE NOT RETURNED.
Description of Event or Problem · 1
ON (B)(6) 2015, ACUFOCUS, INC. BECAME AWARE OF AN INLAY BEING EXPLANTED FROM THE RIGHT EYE OF A (B)(6), FEMALE PATIENT, 37 DAYS POSTOPERATIVELY DUE TO A CENTRAL, STERILE, WHITE INFILTRATE APPROXIMATELY 1 MM IN DIAMETER IN THE ANTERIOR STROMA. UPON REMOVAL OF THE INLAY IT WAS OBSERVED BY THE SURGEON THAT THE INFILTRATES WERE SUPERFICIAL TO THE POCKET AND NOT WITHIN THE POCKET WHERE THE KAMRA INLAY WAS LOCATED. THE PATIENT RECOVERED AND WAS DISCHARGED BY OPTILASE ON (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 778851 | KAMRA | CORNEAL INLAY | LQE | ACUFOCUS, INC. | 76195 | A530-0214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |