FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYS
MDR report key: 3915493
·
Received February 26, 2014
Report
- Report Number
- 2028159-2014-00267
- Event Type
- Malfunction
- Date Received
- February 26, 2014
- Date of Event
- January 24, 2014
- Report Date
- January 30, 2014
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CTR
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS IN PROGRESS. A SAMPLE IS EXPECTED, BUT HAS NOT BEEN RECEIVED FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE PROBE DID NOT ASPIRATE SUDDENLY DURING SURGERY. THE HANDPIECE AND THE PAK WERE EXCHANGED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118247 | INFINITI VISION SYS | PHACOFRAGMENTATION SYS | HQC | ALCON - IRVINE TECHNOLOGY CTR | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | 1..1 MM INFUSION PAK |