FDA Adverse Event Injury Summary report: N

INFINITI VISION SYSTEM OZIL

MDR report key: 2921716 · Received January 15, 2013

Report

Report Number: 2028159-2013-00057
Event Type: Injury
Date Received: January 15, 2013
Date of Event: December 19, 2012
Report Date: December 19, 2012
Manufacturer: ALCON - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K082845
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED EVENT OF "SYSTEM DID NOT ASPIRATE". AN UNREPORTED EVENT OF SYSTEM HAD INSUFFICIENT PHACO POWER" WAS NOTED DURING THE SYSTEM EVAL. THE COMPANY REP RESOLVED THE UNREPORTED EVENT BY REPLACING THE U/S (ULTRASOUND) HANDPIECE CABLE ASSEMBLY. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. 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 2 SIMILAR REPORTS FOR THIS SYSTEM. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

Description of Event or Problem · 1

A NURSE TECH REPORTED THE EQUIPMENT DID NOT ASPIRATE DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT, BUT WITH ANOTHER HANDPIECE AND TIP, FOLLOWING A DELAY OF MORE THAN 15 MINUTES. THE PT EXPERIENCED A CAPSULE TEAR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
22225	INFINITI VISION SYSTEM OZIL	PHACOFRAGMENTATION SYSTEM	HQC	ALCON - IRVINE TECHNOLOGY CENTER	INFINITI OZIL	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other