BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3040101 · Received April 3, 2013

    Report

    Report Number
    1119421-2013-00346
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    January 1, 2007
    Report Date
    March 6, 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
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT WAS NOT RETURNED AND NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. NO CONTACT INFO WAS PROVIDED FOR THE CONSUMER OR THE SURGEON; THEREFORE, FOLLOW UP CANNOT BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED VIA A SOCIAL MEDIA FORUM THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE/SHE HAS HAD LIMITED CLOSE-UP VISION IN BRIGHT LIGHT AND IMAGES ARE LARGER IN THE LEFT EYE. THE PT HAS A DIFFERENT BRAND OF MULTIFOCAL IOL IMPLANTED IN THE RIGHT EYE. THIS HAS CONTRIBUTED TO "ODD EFFECTS" AND HAS LIVED WITH IT RATHER UNHAPPILY. NO CONTACT INFO WAS PROVIDED FOR THE CONSUMER OR THE SURGEON; THEREFORE, FOLLOW UP CANNOT BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135882 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other REZOOM IOL IN RIGHT EYE