BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3812593 · Received May 7, 2014

    Report

    Report Number
    1119421-2014-00316
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    November 27, 2013
    Report Date
    April 7, 2014
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR AND IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE EXPERIENCED SMEARING ON THE LENS AND PUPIL DID NOT DILATE. THE PT EXPERIENCED UNCLEAR VISION AND A LOT OF FLARE, SPECIALLY WITH SIDE-LIGHTING. THE CONSUMER WAS TREATED WITH FLUOROMETHOLONE TWICE A DAY DURING A FORTNIGHT AND THEN ONCE A DAY FOR A FORTNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276644 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6CWS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FLUOROMETHOLONE (DATE UNK)