BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3052947 · Received April 5, 2013

    Report

    Report Number
    1119421-2013-00362
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 11, 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
    RS
    Reporter Occupation
    NOT APPLICABLE

    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 INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HER INTRAOCULAR PRESSURE (IOP) INCREASED FROM 20 MM HG PREOPERATIVELY TO 31 MM HG. SHE ALSO BEGAN TO SEE SPOTS IN FRONT OF HER EYE. THE CONSUMER REPORTED THAT HER ELEVATED IOP WAS TREATED WITH MEDICATIONS. SHE EXPERIENCED IRRITATION AND REDNESS FROM THE MEDICATIONS, SO THE MEDICATIONS WERE CHANGED. HER INTRAOCULAR PRESSURE RESPONDED INITIALLY TO THE MEDICATIONS, BUT AT THE TIME OF THE REPORT, WAS BACK UP TO 20 MM HG. THE CONSUMER REPORTED WHEN SHE IS IN MORE LIGHT, SHE SEES MORE DOTS BEFORE HER EYES. THIS HAS CAUSED HER TO HAVE TO WEAR DARK GLASSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139902 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 12179278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention