BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1033564 · Received April 2, 2008

    Report

    Report Number
    1119421-2008-00205
    Event Type
    Injury
    Date Received
    April 2, 2008
    Report Date
    March 3, 2008
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS. PROD HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. SOURCE OF EVENT IS PUBLISHED LITERATURE. LENS MODEL INVOLVED IS NOT MEANT FOR PLACEMENT IN THE CILIARY SULCUS. ADD'L INFO WAS REQUESTED AND RECEIVED FROM THE SURGEON IN 2008.

    Description of Event or Problem · 1

    JOURNAL ARTICLE REPORTED A PT WITH AN INTRAOCULAR LENS (IOL) IMPLANT HAD A "RUNAROUND" ANTERIOR-TO-POSTERIOR CAPSULE TEAR. THE LENS WAS PLACED IN THE SULCUS AND THE PT'S VISION FLUCTUATED. THE LENS WAS DECENTERED NASALLY. ADD'L INFO RECEIVED FROM THE SURGEON REPORTED HE EXCHANGED THE LENS WITH A DIFFERENT LENS MODEL AND SUTURED IT TO THE IRIS. THE PT IS DOING VERY WELL AND IS HAPPY WITH THE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention