BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1894955 · Received November 5, 2010

    Report

    Report Number
    1119421-2010-01217
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    May 26, 2010
    Report Date
    October 7, 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
    NC, 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. THE HCP REPORTED THE USE OF AN UNAPPROVED VISCOELASTIC FOR THIS LENS/CARTRIDGE COMBINATION. ADDITIONAL INFO WAS REQUESTED ON 10/11/2010, 10/14/2010, AND 10/20/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/20/2010. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCING HALOS AROUND LIGHTS AT NIGHT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE PT STATED THE HALOS APPEAR AROUND LIGHTS IN THE DARK AND SEMI-DARK CONDITIONS AND WAS MAKING DRIVING VERY DIFFICULT. THE SURGEON REPORTED THAT MEDICATIONS WERE TRIED TO REDUCE THE PUPIL SIZE IN AN EFFORT TO ELIMINATE THE HALOS. THE HCP REPORTED THE USE OF AN UNAPPROVED VISCOELASTIC FOR THIS LENS/CARTRIDGE COMBINATION. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT CONTINUES. THE PT CONTINUES TO USE THE MEDICATION. 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 10959106

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention VISCOAT/PROVISC| ACUVAIL| MONARCH "D" CARTRIDGE