BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3111294 · Received May 9, 2013

    Report

    Report Number
    1119421-2013-00518
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A PARTIAL COMPLETED QUESTIONAIRE WAS RECEIVED ON (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCING STREAKS, STARBURSTS AND DECREASED NIGHT VISION FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE LENS WAS EXCHANGED FOR A MONOFOCAL LENS. IN A F/U, THE SURGEON REPORTED THE PT DESCRIBED "LIGHTS LOOK LIKE CITIES," TRAIL OF LIGHT", ALSO SEEING A HALF MOON ABOVE AND SOMETIMES TO THE SIDE AND BELOW. THE SYMPTOMS DECREASED FOLLOWING THE LENS EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204993 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 12185263

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VISCOAT| LENSX