BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3233798 · Received July 16, 2013

    Report

    Report Number
    1119421-2013-00764
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    September 1, 2010
    Report Date
    June 18, 2013
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, HE CANNOT READ WITHOUT A BRIGHT LIGHT, ENJOY HIS COMPUTER, TELEVISION OR GO ANYWHERE WITHOUT WARING DARK GLASSES. THE CONSUMER REPORTED HE NOW HAS MACULAR DEGENERATION POSSIBLY CAUSED BY DAMAGE DURING HIS PROCEDURE IN THE LEFT EYE. ADDITIONAL INFO WAS REQUESTED, THE SURGEON REPLIED HE IS UNWILLING TO COMPLETE THE QUESTIONNAIRE. HE REPORTED THE LENS IS POSITIONED AND CENTERED AS IT SHOULD BE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328661 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON - FORT WORTH/ALCON LABORATORIES, INC. SN6AD1 10904915

    Patients

    Seq Age Sex Outcome Treatment
    1 Other