FDA Adverse Event Malfunction Summary report: N

INFINITI VISION SYSTEM OZIL

MDR report key: 2925360 · Received January 17, 2013

Report

Report Number: 2028159-2013-00062
Event Type: Malfunction
Date Received: January 17, 2013
Date of Event: December 12, 2012
Report Date: December 17, 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: NY, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) TO ASSIST WITH TROUBLESHOOTING. THE TSS CONFIRMED WITH THE CUSTOMER THAT THE FOOTSWITCH WAS RESPONDING AS EXPECTED. THE CUSTOMER WAS ADVISED TO MONITOR THE PHACO HANDPIECE STATUS AND VERIFY THAT THE SYSTEM INDICATOR IS GREEN AFTER TUNING. THE CUSTOMER DID NOT REQUEST SERVICE OR CONTACT THE TSS FOR FURTHER ASSISTANCE. 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 INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

Description of Event or Problem · 1

A CUSTOMER REPORTED THE SYSTEM QUIT WORKING WHEN THEY WENT INTO THE SURGERY SCREEN DURING A PROCEDURE. ADD'L INFO WAS REC'D FROM THE CUSTOMER INDICATING THERE WAS NO SUCTION WHEN IN PHACO MODE AND THE MACHINE STOPPED WORKING. THE HANDPIECE WAS EXCHANGED, BUT THE ISSUE PERSISTED. THE SYSTEM WAS EXCHANGED TO COMPLETE THE CASE FOLLOWING A 15 MIN DELAY. THERE WAS NO HARM TO THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
25414	INFINITI VISION SYSTEM OZIL	PHACOFRAGMENTATION SYSTEM	HQC	ALCON - IRVINE TECHNOLOGY CENTER	INFINITI OZIL	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1