BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4811765 · Received June 2, 2015

    Report

    Report Number
    1119421-2015-05496
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    June 2, 2015
    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
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; IT REMAINS IMPLANTED. THE 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 ADDITIONAL INFORMATION BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED APPROXIMATELY ONE WEEK FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY HE NOTED HAZY VISION AT DISTANCE AND NEAR. THE HAZY VISION BECAME WORSE FOLLOWING DISCONTINUATION OF POST-SURGERY EYE DROPS. HE ALSO REPORTS SEEING STARBURSTS AND DOUBLE LIGHTS WHEN DRIVING AT NIGHT ONLY WITH THE POSTOPERATIVE EYE, AND A CHANGED DEPTH PERCEPTION PLAYING GOLF. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356655 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. - HUNTINGTON SN60WF 12325326

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other