FDA Adverse Event
Injury
Summary report: N
KAMRA
MDR report key: 5210069
·
Received November 9, 2015
Report
- Report Number
- 3008401069-2015-00009
- Event Type
- Injury
- Date Received
- November 9, 2015
- Date of Event
- January 29, 2014
- 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).
Additional Manufacturer Narrative · 1
PATIENT CODES WERE CORRECTED TO REFLECT INFILTRATE AND CORNEAL ULCER BASED ON THE RESULTS OF THE INVESTIGATION.
Description of Event or Problem · 1
ON OCTOBER 09, 2015, ACUFOCUS, INC. BECAME AWARE OF AN INLAY BEING EXPLANTED APPROXIMATELY FOUR (4) MONTHS POSTOPERATIVELY DUE TO AN INFLAMMATORY REACTION WHICH MANIFESTED AS HAZE, INFILTRATES, AND REDUCED VISUAL ACUITY (VA). THE INFLAMMATION WAS NOTED TO REOCCUR AS SOON AS PRED FORTE EYE DROPS WERE DISCONTINUED. ONE (1) DAY FOLLOWING THE REMOVAL OF THE INLAY, ON (B)(6) 2014, THE PATIENT WAS REFERRED TO THE (B)(6) HOSPITAL, AND WAS DIAGNOSED WITH LEFT EYE POST OPERATIVE MICROBIAL KERATITIS. THE AFOREMENTIONED HOSPITAL PRESCRIBED VANCOMYCIN, CEFTAZIDINE, CYCLOPENTOLATE, AND PRED. MINIMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 741705 | KAMRA | CORNEAL INLAY | LQE | ACUFOCUS, INC. | ACI 7000 | A424-0912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |