BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2950068 · Received February 6, 2013

    Report

    Report Number
    1119421-2013-00108
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR A TORIC MODEL LENS OF SIMILAR POWER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE TECHNICIAN, WHO REPORTED THE PATIENT HAD CYLINDER REFRACTION AFTER THE MULTIFOCAL LENS WAS IMPLANTED. THE TECHNICIAN DID NOT KNOW WHETHER THE IOL CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50123 ACRYSOF RESTOR INTRAOCULAR LENS HQL SN6AD1 12149999

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention