FDA Adverse Event Injury Summary report: N

ACRYSOF

MDR report key: 1893231 · Received November 1, 2010

Report

Report Number: 1119421-2010-01196
Event Type: Injury
Date Received: November 1, 2010
Date of Event: August 1, 2010
Report Date: October 2, 2010
Manufacturer: ALCON RESEARCH. LTD. / HUNTINGTON
Product Code: HQL
PMA / PMN Number: P930014
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN ON OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED AND RECEIVED. (B)(4).

Description of Event or Problem · 1

A SURGEON REPORTED SEVEN ADDITIONAL CASES OF INFLAMMATION AND CELLS IN THE ANTERIOR CHAMBER FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ALL OF THE SURGERIES INVOLVED UNCOMPLICATED CASES AND IOL IMPLANTATION. THE DURATION OF THE SURGERIES VARIED BETWEEN 17 AND 25 MINUTES. SOME PATIENTS (NOT SPECIFIED) WERE GIVEN PREOPERATIVE ARTIFICIAL TEARS OR GLAUCOMA MEDICATION. THE SURGEON STATED THAT MOST PATIENTS WILL BE FOLLOWED UP IN A COUPLE OF MONTHS. IN A FOLLOW UP CONVERSATION WITH THE SURGEON, HE REPORTED HE IS NO LONGER ADDING LEVORENINE AND GEOMYCIN TO THE BSS AND THAT HE HAS IMPROVED HIS TECHNIQUE IN SURGERY. THE SURGEON REPORTED HE HAS NOT HAD ANY NEW CASES OF INFLAMMATION RECENTLY. THIS IS A BILATERAL FILE AND THIS REPORT IS FOR THE LEFT EYE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACRYSOF	INTRAOCULAR LENS	HQL	ALCON RESEARCH. LTD. / HUNTINGTON	SN60WF	10844088

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention	BSS (WITH LEVORENINE AND GEOMYCIN)\| LINISOL\| INDOCOLLYRE