BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1615742 · Received February 19, 2010

    Report

    Report Number
    1119421-2010-00153
    Event Type
    Injury
    Date Received
    February 19, 2010
    Date of Event
    February 1, 2009
    Report Date
    January 21, 2010
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    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 BEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITION INFORMATION WAS REQUESTED ON 01/22/2010, 021/10/2010, AND 02/11/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B) (4)

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAD NOTICED SHADOWING AROUND LETTERS AT DISTANCE AND NEAR, HAS DIFFICULTY DRIVING AT NIGHT DUE TO HALOS AROUND LIGHTS, AND HAS DIFFICULTY READING IN LOW LIGHTING CONDITIONS. THE SURGEON PRESCRIBED GLASSES FOR HER TO WEAR WHILE DRIVING AT NIGHT AND EYE DROPS. THESE MEASURES HAVE "BEEN OF LITTLE HELP". THE CONSUMER REPORTED THAT OVERALL SHE IS VERY SATISFIED WITH HER VISION, BECAUSE PRIOR TO SURGERY SHE HAD BINOCULAR VISION AND WAS WEARING PRISM GLASSES. NOW HER DOUBLE VISION IS MONOCULAR, BUT TOLERABLE. THE CONSUMER REPORTED THAT A YAG LASER PROCEDURE HAD BEEN PERFORMED DUE TO POSTERIOR CAPSULE OPACIFICATION. THE CONSUMER SPOKE WITH HER PHYSICIAN WHO FEELS HER ISSUES ARE RELATED TO DRY EYES AND EYE FATIGUE. ADDITIONAL INFORMATION 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 SN6AD1 10870112

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 25 OTHER UNK MEDICATIONS| PREDNISONE 20 MG EVERY OTHER DAY,