FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 1002343
·
Received February 22, 2008
Report
- Report Number
- 1644019-2008-00003
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- January 10, 2008
- Report Date
- January 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
- RO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THIS REPORT MAILED IN TO FDA ON: 2/22/2008.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING SURGERY, THE ANTERIOR CHAMBER COLLAPSED. THE ANTERIOR CHAMBER COLLAPSE OCCURRED DURING PHACO AND DURING I/A. THE SURGEON CONVERTED TO AN ECCE TO COMPLETED THE CASE AND THE PT WAS HOSPITALIZED FOR THREE DAYS AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM | OPHTHALMIC SURGERY SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization |