FDA Adverse Event Malfunction Summary report: N

INFINITI VISION SYSTEM OZIL

MDR report key: 2043047 · Received March 25, 2011

Report

Report Number: 2028159-2011-00296
Event Type: Malfunction
Date Received: March 25, 2011
Report Date: February 23, 2011
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: AL, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE COMPANY REP EXAMINED THE SYSTEM AND VERIFIED THE SURGEON SETTINGS. PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED; THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE HOST BATTERY, REMOTE CONTROL BATTERIES, AND SOLENOID SPACERS WERE REPLACED AS PART OF THE PM. A WORN FOOTSWITCH CABLE WAS ALSO REPLACED, ALTHOUGH NOT RELATED TO THE REPORTED EVENT. NO SAMPLES WERE RETURNED, THEREFORE STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNK AT THIS TIME. HOWEVER INFO RECEIVED FROM THE CUSTOMER NOTED THE EVENT WAS NOT RELATED TO THE FUNCTION OF THE SYSTEM; IT WAS A MISUNDERSTANDING ON THE PART OF THE DOCTOR. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/25/2011. (B)(4).

Description of Event or Problem · 1

A CUSTOMER REPORTED A PROBLEM WITH THE DOCTOR'S SETTINGS IN THE SYSTEM. THE SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE. ADDITIONAL INFO WAS RECEIVED INDICATING THIS EVENT WAS NOT IN ANY WAY RELATED TO THE FUNCTION OF THE SYSTEM, BUT INSTEAD WAS A MISUNDERSTANDING ON THE PART OF THE SURGEON. THE CUSTOMER WAS UNWILLING TO PROVIDE ANY FURTHER INFO. THERE WAS NO PT HARM REPORTED.

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