FDA Adverse Event Malfunction Summary report: N

INFINITI VISION SYSTEM

MDR report key: 4821719 · Received June 5, 2015

Report

Report Number: 2028159-2015-06340
Event Type: Malfunction
Date Received: June 5, 2015
Date of Event: May 20, 2015
Report Date: September 10, 2015
Manufacturer: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K120912
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER REPORTED THAT THE SYSTEM HAD NO PHACO POWER DURING A PROCEDURE. THE CUSTOMER ATTEMPTED TO RESOLVE THE REPORTED EVENT BY RESTARTING THE SYSTEM AND RETESTING 2 DIFFERENT HANDPIECES BUT WAS UNSUCCESSFUL. THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT BE REPLICATE THE PROBLEM REPORTED. THE ULTRASOUND (US) CONTROLLER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS REPLACED FOR DIAGNOSTIC PURPOSES. PREVENTIVE MAINTENANCE (PM) WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SYSTEM WAS MANUFACTURED ON JULY 30, 2007. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative · 1

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

A CUSTOMER REPORTED THAT THERE WAS NO SYSTEM PHACO POWER DURING A CASE. THE CASE WAS COMPLETED USING THE SAME SYSTEM. THERE WAS NO HARM TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
365655	INFINITI VISION SYSTEM	UNIT, PHACOFRAGMENTATION	HQC	ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other