FDA Adverse Event
Injury
Summary report: N
IFINITI VISION SYSTEM
MDR report key: 1243150
·
Received November 21, 2008
Report
- Report Number
- 2028159-2008-00422
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- September 30, 2008
- Report Date
- October 23, 2008
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A PHOTOGRAPH OF THE COMPLAINT SAMPLE WAS RECEIVED WITH THE PARTICLE TO BE SENT FOR IN HOUSE TESTING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE SURGEON REPORTED A FOREIGN PARTICLE LIKE IRON POWDER WAS FOUND AFTER THE POST OPERATIVE EXAMINATION. THE PARTICLE WAS REMOVED. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IFINITI VISION SYSTEM | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |