BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3062913 · Received April 12, 2013

    Report

    Report Number
    1119421-2013-00391
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    November 19, 2012
    Report Date
    March 15, 2013
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH RESIDUAL CYLINDER FOLLOWING MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY WITH LIMBAL RELAXING INCISIONS (LRIS). ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO STATED THAT THE PATIENT WAS UNABLE TO NEURO-ADAPT TO THE MULTIFOCAL LENSES. THE PATIENT IS (B)(6) AND IS UNABLE TO SEE NUMBERS, AND DRIVING AT NIGHT IS DIFFICULT. IN HIS OPINION, THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AND THE PATIENT HAS POOR QUALITY OF VISION IN EACH EYE. THE PATIENT HAD BOTH LENSES EXCHANGED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159093 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./ HUNTINGTON SN6AD1 12136981

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other MONARCH CARTRIDGE