FDA Adverse Event Malfunction Summary report: N

INFINITI VISION SYSTEM OZIL

MDR report key: 3130336 · Received May 22, 2013

Report

Report Number: 2028159-2013-01004
Event Type: Malfunction
Date Received: May 22, 2013
Date of Event: April 25, 2013
Report Date: April 25, 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: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE FACILITY BIOMED TECH CALLED THE COMPANY TECH SUPPORT SPECIALIST (TSS) TO ASSIST WITH TROUBLESHOOTING. THE TSS ASSISTED THE FACILITY BIOMED TECH COMPLETE A COPY BACKUP OF THE SYSTEM SETTINGS TO THIS SYSTEM. THE FACILITY BIOMED TECH BELIEVED THE ISSUE WAS RELATED TO OPERATOR ERROR DUE TO THE CUSTOMER PUSHING THE WRONG BUTTON. UPON RESTORING THE SYSTEM FROM BACKUP, SERVICE WAS CANCELED PER THE CUSTOMER'S REQUEST. 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. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. PER THE CUSTOMER, THE ROOT CAUSE WAS LIKELY RELATED TO USER ERROR DUE TO PUSHING THE WRONG BUTTON. (B)(4).

Description of Event or Problem · 1

A BIOMEDICAL ENGINEER REPORTED THE SYSTEM'S MEMORY WAS LOST DURING A PROCEDURE. FOLLOWING A 30 MINUTE DELAY, AN ALTERNATE SYSTEM WAS USED TO COMPLETED THE PROCEDURE WITH NO HARM TO THE PT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE BIOMEDICAL ENGINEER REPORTING THAT THIS EVENT MAY HAVE BEEN CAUSED BY AN OPERATOR ERROR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
226898	INFINITI VISION SYSTEM OZIL	PHACOFRAGMENTATION SYSTEM	HQC	ALCON - IRVINE TECHNOLOGY CENTER	INFINITI OZIL	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1