FDA Adverse Event Other Summary report: N

ACRYSOF

MDR report key: 1891621 · Received October 20, 2010

Report

Report Number: 1119421-2010-01143
Event Type: Other
Date Received: October 20, 2010
Date of Event: May 7, 2009
Report Date: September 20, 2010
Manufacturer: ALCON RESEARCH, LTD. / HUNTINGTON
Product Code: HQL
PMA / PMN Number: P930014
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, 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. ADD'L INFO WAS REQUESTED ON 09/21/2010, 09/23/2010, AND 09/29/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

Description of Event or Problem · 1

A SURGEON REPORTED NOTING AN INTRAOCULAR LENS (IOL) HAD HAZY QUALITIES FOLLOWING IMPLANT SURGERY. THE SURGEON REPORTED THE PATIENT IS EXPERIENCING STARBURSTS AND FEELS THE HAZY IOL MAY BE CAUSING THE STARBURSTS TO BE WORSE. THE SURGEON NOTED THE HAZY AREA ON THE IOL AT ONE WEEK POSTOP, BUT THE PT HAD NO REPORTED PROBLEMS AT THAT TIME. THE SURGEON REPORTED THE PATIENT NOTICED THE STARBURSTS AT APPROX ONE MONTH POSTOP, BUT THEY HAVE BECOME WORSE IN THE LAST THREE TO FOUR MONTHS. THE SURGEON STATED THE HAZY AREA WAS LIKE WHAT HE WOULD ENCOUNTER WITH SILICONE. THE PT'S UCVA WAS NOTED TO BE 20/20. THE SURGEON STATED HE IS NOT PLANNING ANY INTERVENTION AT THE PRESENT TIME. ADD'L INFO HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACRYSOF	INTRAOCULAR LENS	HQL	ALCON RESEARCH, LTD. / HUNTINGTON	SN60WF	10867925

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Other