FDA Adverse Event Injury Summary report: N

INFINITI VISION SYSTEM OZIL

MDR report key: 3771006 · Received December 18, 2013

Report

Report Number: 2028159-2013-02327
Event Type: Injury
Date Received: December 18, 2013
Date of Event: November 22, 2013
Report Date: November 22, 2013
Manufacturer: ALCON - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K082845
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND THE SYSTEM MESSAGE REPORTED COULD NOT BE REPLICATED. THE COMPANY REPRESENTATIVE DEMONSTRATED THE CREATION OF THE REPORTED SYSTEM MESSAGE WITH THE CUSTOMER'S BIOMED TECHNICIAN AND CONFIRMED THAT THE REPORTED SYSTEM MESSAGE WAS DUE TO THE MISUSE OF SYSTEM FUNCTIONS. THE COMPANY REPRESENTATIVE PROVIDED THE RECOMMENDATIONS OF THE PROPER USE DO THE SYSTEM FUNCTIONS. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE FOR THE REPORTED EVENT WAS ATTRIBUTED TO IMPROPER USE OF SYSTEM FUNCTIONS. (B)(4).

Description of Event or Problem · 1

A BIOMEDICAL ENGINEER REPORTED SYSTEM MESSAGES DISPLAYED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS OBTAINED FROM A NURSE AT THE FACILITY. THE SYSTEM MESSAGES OCCURRED DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. A DIFFERENT SURGEON WAS BROUGHT IN TO PERFORM THE CATARACT REMOVAL USING A MANUAL PROCEDURE INSTEAD OF USING THE SYSTEM FOR PHACOEMULSIFICATION. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
664300	INFINITI VISION SYSTEM OZIL	PHACOFRAGMENTATION SYSTEM	HQC	ALCON - IRVINE TECHNOLOGY CENTER	INFINTI OZIL	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other