FDA Adverse Event Malfunction Summary report: N

ACRYSOF RESTOR

MDR report key: 1172584 · Received September 19, 2008

Report

Report Number: 1119421-2008-00738
Event Type: Malfunction
Date Received: September 19, 2008
Date of Event: August 21, 2008
Report Date: August 21, 2008
Manufacturer: ALCON RESEARCH, LTD/HUNTINGTON
Product Code: MFK
PMA / PMN Number: P040020
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
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 NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 08/22/2008 AND 08/25/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 09/02/2008. THIS REPORT WAS MAILED TO FDA ON: 09/19/2008.

Description of Event or Problem · 1

A SURGEON REPORTS NOTICING AN AIR BUBBLE IN THE VISUAL AXIS OF AN INTRAOCULAR LENS (IOL) AFTER IMPLANT SURGERY. ALTHOUGH THE PATIENT'S VISION HAS IMPROVED POSTOPERATIVELY, THE SURGEON AND THE PATIENT ARE DISSATISFIED WITH THE RESULTS. THE PATIENT WAS SEEN BY ANOTHER SURGEON. UPON EXAMINATION, HE CONCLUDED THERE WAS NOT A PROBLEM WITH THE LENS, BUT FOLDS WERE OBSERVED IN THE POSTERIOR CAPSULE. THE SURGEON RECOMMENDED A YAG AND MINI RK PROCEDURE BE PERFORMED TO CORRECT THE SMALL REFRACTIVE ERROR. THE PATIENT IS REPORTED TO BE "DOING WELL".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACRYSOF RESTOR	INTRAOCULAR LENS	MFK	ALCON RESEARCH, LTD/HUNTINGTON	SN60D3	10722170

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR			SILICONE I&O