BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3214038 · Received July 3, 2013

    Report

    Report Number
    1119421-2013-00734
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    June 10, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED FOR THE ASSOCIATED CARTRIDGE BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN, REPORTED A PATIENT EXPERIENCED DYSPHOTOPSIA, BLURRED VISION, AND FLUTTERING, TEMPORAL IN THE LEFT EYE FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE LENS WAS REMOVED AND EXCHANGED WITH AN UNKNOWN IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304450 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD3 12096418

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention DUOVISC| MONARCH D CARTRIDGE| MONARCH III HANDPIECE