FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 2903305
·
Received December 14, 2012
Report
- Report Number
- 2028159-2012-01950
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Date of Event
- November 15, 2012
- Report Date
- November 15, 2012
- 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
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REP EXAMINED THE SYSTEM AND NO PROBLEMS WERE FOUND. THE COMPANY REP CHECKED THE CUSTOMER'S HANDPIECES AND NO PROBLEMS WERE FOUND. THE SOFTWARE WAS UPDATED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED NO IRRIGATION AND ASPIRATION DURING A CATARACT EXTRACTION PROCEDURE. THE SYSTEM WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.
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 |