BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3181423 · Received June 14, 2013

    Report

    Report Number
    1119421-2013-00662
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 18, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON NOTED THAT HE HAS ABOUT ONE IN TEN PTS THAT REPORTED EXPERIENCING NEGATIVE DYSPHOTOPSIA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES. THESE PTS TYPICALLY REPORTED A SHADOW OBSTRUCTING THE TEMPORAL FIELD OF VISION. THE PT WOULD REPORT A FEELING AS IF HIS/HER EYE WAS CONSTRICTED FROM THE LATERAL SIDE. SOME PTS WOULD REPORT THIS AS A CONSTANT FLICKERING OF THE VISION TEMPORALLY. THE EVENT WOULD SUBSIDE FOLLOWING THE USE OF DILATOR EYE DROPS OF SUNGLASSES. THE SURGEON REPORTED THAT HE IS USING A DIFFERENT MODEL LENS NOW AND IS SEEING ONE IN FOUR PTS REPORTING DYSPHOTOPSIA. THE SURGEON DOES NOT FEEL THE PROBLEM IS RELATED TO THE SITE OF INCISION OR THE SIZE OF THE PUPIL, AS YOUNGER PTS WITH WIDER PUPILS ARE ALSO REPORTING NEGATIVE DYSPHOTOPSIA. THE SYMPTOMS ARE HIGHLY DISTURBING TO THE PT AND THEY INCREASE THE PTS DISSATISFACTION. THE SURGEON WONDERS IF THE SQUARE EDGE DESIGN OF THE LENSES CONTRIBUTES TO THESE EVENTS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST LENS MODEL GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272126 ACRYSOF INTRAOCULAR LEN HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention