ETERNITY NAVI XJ-70

Report

Report Number: 2031924-2011-00108
Event Type: Injury
Date Received: May 26, 2011
Date of Event: April 21, 2011
Report Date: April 29, 2011
Manufacturer: B+L FOR ADVANCED VISION SYSTEM (AVS)
Product Code: HQL
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

AN INVESTIGATION REPORT RECEIVED FROM THE MANUFACTURER (AVS) INDICATES THAT THE EVENT MAY HAVE BEEN DUE TO MIS-LOADING OF THE LENS IN THE FOLDER, CAUSING ONE HAPTIC TO BECOME TRAPPED. ACCORDING TO THE MANUFACTURER, THE LOT NUMBER OF THE INJECTOR IS EITHER 022658, 022661, OR 024024. THE DEVICE HISTORY RECORDS WERE REVIEWED BY THE MANAGER AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE.

Description of Event or Problem · 1

THE SURGEON REPORTED THAT THE ETERNITY; X-70 WAS SET INTO THE FOLDER OF THE ETERNITY NAVI; XJ-70. BEFORE CLOSING THE FOLDER, THE LENS POSITION WITHIN THE FOLDER WAS CHECKED. AFTERWARD THE FOLDER WAS LOADED TO THE INJECTOR BODY. THE LENS WAS INSERTED INTO THE RIGHT EYE W/O ANY DISCOMFORT IN PUSHING THE PLUNGER. HOWEVER RIGHT AFTER THE INSERTION, IT WAS NOTICED THAT THE LEADING HAPTIC WAS MISSING. BECAUSE THE OPTIC HAD ALREADY UNFOLDED IN THE EYE, THE LENS WAS CUT AND REMOVED FROM THE EYE. ADDITIONAL INFORMATION INDICATED A REPLACEMENT X-70 LENS WAS INSERTED WITH XJ-70. AFTER THE INSERTION WAS COMPLETED, POSTERIOR CAPSULE TEAR WAS FOUND. VITRECTOMY WAS PERFORMED TO AVOID VITREOUS PROLAPSE. MOST CURRENT POST OPERATIVE VISIT (DATE UNKNOWN) REVEALED NO INFLAMMATION AND THE PATIENT'S VISUAL ACUITY WAS SATISFACTORY. PLEASE REFERENCE MDR# 2031924-2011-00107

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ETERNITY NAVI XJ-70	NONE	HQL	B+L FOR ADVANCED VISION SYSTEM (AVS)	XJ-70

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	ETERNITY X-70 IOL