BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4151978 · Received October 6, 2014

    Report

    Report Number
    1119421-2014-00765
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    June 1, 2014
    Report Date
    September 10, 2014
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINED IMPLANTED. PRODUCT INFORMATION WAS PROVIDED. 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 WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AFTER INTRAOCULAR LENSES (IOL) WERE IMPLANTED BILATERALLY, THE PATIENT REPORTED HALOS, GLARE AND FEELS HER READING VISION IS NOT GOOD. IN A FOLLOW UP, THE SURGEON REPORTED THAT EXCHANGING THE LENSES HAS BEEN DISCUSSED AS AN OPTION THAT IS BEING CONSIDERED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624371 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12232748

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other MONARCH HANDPIECE| DISCOVISC| MONARCH D CARTRIDGE