FDA Adverse Event Malfunction Summary report: N

CONSTELLATION VISION SYSTEM

MDR report key: 4823914 · Received June 8, 2015

Report

Report Number: 2028159-2015-06344
Event Type: Malfunction
Date Received: June 8, 2015
Report Date: September 3, 2015
Manufacturer: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K101285
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS NOT REPLICATED. THE FOOTSWITCH CABLE (WHICH BELONGS TO THE SYSTEM) WAS REPLACED TO ADDRESS THE ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE SYSTEM WAS MANUFACTURED ON FEBRUARY 12, 2014. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE BROKEN FOOTSWITCH CABLE. HOWEVER, HOW OR WHEN THE CABLE BECAME BROKEN CANNOT BE DETERMINED CONCLUSIVELY. (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. (B)(4).

Description of Event or Problem · 1

A CUSTOMER REPORTED EXPERIENCING A FOOTSWITCH ISSUE BEFORE SURGERY. AN ALTERNATE SYSTEM WAS USED TO PROCEED WITH SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
369035	CONSTELLATION VISION SYSTEM	UNIT, PHACOFRAGMENTATION	HQC	ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER	TABLETOP	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other