BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1943617 · Received December 14, 2010

    Report

    Report Number
    1119421-2010-01385
    Event Type
    Other
    Date Received
    December 14, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    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 INFO WAS REQUESTED ON 11/24/2010 AND 12/09/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 11/23/2010. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, HER NEAR AND INTERMEDIATE VISION IN BOTH EYES HAVE WORSENED, THE RIGHT EYE BEING WORSE THAN THE LEFT EYE. SHE REPORTED THAT LETTERS HAVE A SHADOW BEHIND THEM AND LIGHTS AT NIGHT ARE PAINFUL. SHE ALSO REPORTED SEEING HALOS AROUND LIGHTS AND THAT THEY HAVE A "SPIDER WEB" EFFECT ON THEM. THE CONSUMER REPORTED HER DISTANCE VISION IS EXCELLENT. MEDICAL RECORDS WERE REQUESTED. THE CONSUMER HAD A HISTORY OF FUCH'S CORNEAL DYSTROPHY, DRY EYES, EMPHYSEMA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERCHOLESTEROLEMIA, SKIN CANCER, AND CORONARY ARTERY BYPASS SURGERY (PRE-EXISTING). ON HER FIRST POSTOPERATIVE DAY, THE CONSUMER REPORTED REDNESS TO HER RIGHT UPPER EYELID AND THAT HER EYES FELT GRITTY. SHE FELT THAT SHE MIGHT BE ALLERGIC TO HER EYE DROPS. AT HER FIVE WEEK POSTOPERATIVE VISIT, THE CONSUMER REPORTED HER VISION WAS FUZZY AT ALL DISTANCES. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 11028220

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other ARTIFICIAL TEARS| ADVAIR| STEROID INJECTION IN BACK| WELLBUTRIN| XANAX| TRICOR| DIOVAN| COREG