FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM OZIL
MDR report key: 3130335
·
Received May 22, 2013
Report
- Report Number
- 2028159-2013-01006
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- April 26, 2013
- Report Date
- April 28, 2013
- 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
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT THERE WAS POOR PHACO POWER DURING A PHACOEMULSIFICATION PROCEDURE. AN ALTERNATE SYSTEM WAS USED TO COMPLETE THE PROCEDURE WITH NO IMPACT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227468 | INFINITI VISION SYSTEM OZIL | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI OZIL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | OZIL TORSIONAL PHACO HANDPIECE |