BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2980540 · Received February 21, 2013

    Report

    Report Number
    1119421-2013-00186
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    October 1, 2012
    Report Date
    January 25, 2013
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT WAS NOT RETURNED AND NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN MADE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED PT WITH CONTINUOUS "FLICKERING" OF VISION (POSITIVE DYSPHOTOPSIA) THAT IS NOT IMPROVING AFTER THREE TO FOUR MONTHS OF HAVING THE INTRAOCULAR LENS (IOL) IMPLANTED. THE SURGEON INDICATED THE LENS IS NOT MOVING AND THE PT HAS MINIMAL REFRACTIVE ERROR WHICH CORRECTS TO 20/20 WITH A CONTACT LENS. AN IOL EXCHANGE IS BEING CONSIDERED BUT NOT YET SCHEDULED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75345 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other