FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 1210088
·
Received October 22, 2008
Report
- Report Number
- 2028159-2008-00381
- Event Type
- Injury
- Date Received
- October 22, 2008
- Date of Event
- September 22, 2008
- Report Date
- September 22, 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
- RP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED ON THE EVENT. 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 INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
THE SURGEON REPORTED A POSTERIOR CAPSULE TEAR OCCURRED. ADDITIONAL INFO HAS BEEN REQUESTED ON THE EVENT AND PT STATUS.
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 |