BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3152633 · Received June 5, 2013

    Report

    Report Number
    1119421-2013-00609
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 10, 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
    WI, 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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE ARE NO OTHER COMPLAINTS REPORTED IN THE LOT. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR A MONOFOCAL LENS. ADDITIONAL INFO WAS RECEIVED THAT THE PT REPORTED BLURRY VISION AND DIFFICULTY READING IN LOW LIGHT. IN A F/U AN ADMINISTRATOR REPORTED THE EVENT RESOLVED WITH TREATMENT (LENS EXCHANGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247868 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON. SN6AD1 12121447

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention UNK VISCOELASTIC