FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 1101810
·
Received August 6, 2008
Report
- Report Number
- 1644019-2008-00024
- Event Type
- Injury
- Date Received
- August 6, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 1, 2008
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE VITRECTOMY PROBE WAS RECEIVED FOR TESTING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 08/06/08.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A POSTERIOR CAPSULE TEAR OCCURRED. AN ANTERIOR VITRECTOMY WAS PERFORMED WITH THE VITRECTOMY CUTTER NOT CUTTING CONSTANTLY AND SOMETIMES WOULD STOP CUTTING. THE VITRECTOMY PROBE WAS REPLACED AND THE CASE WAS COMPLETED. THE CUSTOMER STATED THERE WAS NO PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention| S |