FDA Adverse Event
Injury
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 2003607
·
Received February 22, 2011
Report
- Report Number
- 2028159-2011-00160
- Event Type
- Injury
- Date Received
- February 22, 2011
- Date of Event
- January 25, 2011
- Report Date
- January 24, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K082845
- 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
ADDITIONAL INFO REGARDING PRODUCT EVAL IS PENDING. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED DURING A CATARACT EXTRACTION PROCEDURE, A SYSTEM MESSAGE DISPLAYED AND THE CONSOLE STOPPED. THE SYSTEM DID NOT RECOVER AFTER EXCHANGING THE CASSETTE, HANDPIECE AND REBOOT. THE CASE WAS CONVERTED TO AN EXTRACAPSULAR CATARACT EXTRACTION TO CONCLUDE THE SURGERY WITHOUT FURTHER INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |