BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3152639 · Received June 5, 2013

    Report

    Report Number
    1119421-2013-00601
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    January 1, 2012
    Report Date
    May 7, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE CUSTOMER DID NOT PROVIDE ANY CONTACT INFO; THEREFORE, NO F/U COULD BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING HALOS, GLARE AND BLURRY NEAR VISION FOLLOWING BILATERAL INTRAOCULAR (IOL) IMPLANT PROCEDURES. THE CONSUMER REPORTED HER VISION IN THE LEFT EYE IS BETTER, HALOS AND GLARE HAVE DIMINISHED, BUT SHE STILL EXPERIENCES BLURRY NEAR VISION. THE CONSUMER REPORTED SHE MUST HAVE A VERY BRIGHT LIGHT TO READ AND HER VISION IS OBSCURED WHEN DRIVING. THE CONSUMER REPORTED THERE ARE PLANS TO EXCHANGE THE LENS IN THIS EYE. THE CONSUMER DID NOT PROVIDE ANY CONTACT INFO; THEREFORE, NO F/U COULD BE CONDUCTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248065 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12149934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other