FDA Adverse Event Injury Summary report: N

ACRYSOF IQ TORIC

MDR report key: 1772277 · Received July 23, 2010

Report

Report Number: 1119421-2010-00851
Event Type: Injury
Date Received: July 23, 2010
Date of Event: June 1, 2010
Report Date: June 23, 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: TX, 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 06/23/2010, 06/25/2010, 07/06/2010, AND 07/12/2010 BY PHONE, FAX, AND MAIL. ADD'L INFO WAS RECEIVED FROM MEDICAL RECORDS AND FAX CORRESPONDENCE ON 06/28/2010 AND 06/29/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

Description of Event or Problem · 1

ADVERSE EVENT(S): "REFRACTIVE SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "REPOSITIONED THE LENS" (MALPOSITION OF DEVICE [IOL (INTRAOCULAR LENS) IMPLANT]). A TECH REPORTED A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE RECEIVED THAT VERIFIED THE REFRACTIVE SURPRISE AND IN A F/U, THE TECH REPORTED THE SURGEON REPOSITIONED THE IOL THREE WEEKS FOLLOWING THE INITIAL SURGERY. SHE REPORTED THAT AT ONE DAY POST-ROTATION, THE PT'S REFRACTION REVEALED NO CHANGE IN VISUAL ACUITY (VA). ADD'L INFO HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACRYSOF IQ TORIC	INTRAOCULAR LENS	HQL	ALCON RESEARCH, LTD. / HUNTINGTON	SN6AT4	11004057

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention