FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 1970095
·
Received January 14, 2011
Report
- Report Number
- 2028159-2011-00041
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 16, 2010
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K082845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FIELD SERVICE VISIT WAS CANCELLED BY THE CUSTOMER AND NO PARTS WILL BE RETURNED FOR EVALUATION. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT DURING CATARACT SURGERY A SYSTEM MESSAGE OCCURRED WHICH THEY WERE UNABLE TO RESOLVE. THE SYSTEM WAS EXCHANGED AND THE SURGERY WAS COMPLETED. A 2 HOURS DELAY OCCURRED. IT WAS REPORTED THAT THE PT DID NOT EXPERIENCE ANY HARM OR INJURY FROM THE DELAY.
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 | UNK |