BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3022434 · Received March 22, 2013

    Report

    Report Number
    1119421-2013-00311
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 22, 2013
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH BLURRY VISION AND ANISOMETROPIA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON INDICATED THE LENS WAS EXCHANGED FOR THE SAME MODEL WITH 1.5 DIOPTERS LESS IN POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119683 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH. LTD./ HUNTINGTON SN6AD1 12151430

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DUOVISC| MONARCH CARTRIDGE AND HANDPIECE| VISCOAT