INFINITI VISION SYSTEM OZIL

Report

Report Number: 2028159-2011-00322
Event Type: Injury
Date Received: April 7, 2011
Date of Event: March 3, 2011
Report Date: March 8, 2011
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: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A COMPANY REP EXAMINED THE SYS AND COULD NOT DUPLICATE THE PROBLEM REPORTED. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE ROOT CAUSE IS UNK. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/07/2011. (B)(4).

Description of Event or Problem · 1

A CUSTOMER REPORTED DURING A CATARACT EXTRACTION PROCEDURE, A "CHATTERING" NOISE WAS HEARD COMING FROM THE SYS AND THEN THE TUBING CAME APART. THE PT'S ANTERIOR CHAMBER IS REPORTED TO HAVE COLLAPSED DURING THE EVENT. THE PROCEDURE WAS COMPLETED FOLLOWING AN ANTERIOR VITRECTOMY. THE PT IS REPORTED AS DOING WELL AND HAS "NO PROBLEMS." IN A F/U, THE SURGEON REPORTS WHILE HE WAS IRRIGATING (ONE QUAD LEFT), THE TUBING CAME LOOSE FROM THE HANDPIECE. THE PT'S ANTERIOR CHAMBER COLLAPSED AND THE TIP OF THE HANDPIECE PENETRATED THE CAPSULE. THE DOCTOR SUSPECTS THE SCRUB TECH DID NOT DO A GOOD JOB SEATING AND IT WAS LOOSE IN THE OPENING. A "RATTLING" NOISE WAS HEARD COMING FROM THE SYS, HOWEVER THE SURGEON DOES NOT FEEL THIS WAS RELATED TO THE EVENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PT IS REPORT AS DOING WELL AND SEEING 20/20- AT THE TWO WEEK POSTOPERATIVE VISIT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention