BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2800752 · Received October 17, 2012

    Report

    Report Number
    1119421-2012-01288
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    July 1, 2012
    Report Date
    September 17, 2012
    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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE ROOT CAUSE COULD NOT BE DETERMINED. NO ENOUGH INFO WAS PROVIDED FROM THE REPORTER TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFO HAS BEEN REQUESTED BY PHONE, FAX AND MAIL ON (B)(4) 2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, A PT WAS SEEING DARK CIRCLES THAT ARE OBSCURING HER PERIPHERAL VISION IN BOTH EYES, ONLY DURING THE DAY. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other