FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 1940124
·
Received December 22, 2010
Report
- Report Number
- 2028159-2010-02446
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 9, 2010
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K021566
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE, UNK AT THIS TIME. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED LOW ASPIRATION OCCURRED DURING A PROCEDURE. THE SURGERY WAS COMPLETED FOLLOWING A DELAY. NO PT INJURY OR HARM REPORTED.
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 |