BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1210737 · Received October 23, 2008

    Report

    Report Number
    1119421-2008-00836
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    July 1, 2006
    Report Date
    September 23, 2008
    Manufacturer
    ALCON RESEARCH, LTD / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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. ADD'L INFO WAS REQUESTED.

    Description of Event or Problem · 1

    IN AN ARTICLE, A SURGEON REPORTED HAVING A PT WHOSE INTRAOCULAR LENS (IOL) WAS NOTED TO HAVE FORCEPS MARK FOLLOWING IMPLANT SURGERY. FURTHERMORE, THE PHYSICIAN WAS DISSATISFIED WITH BOTH NEAR AND FAR VISION. THE LENS WAS EXCHANGED AND THE PT'S VISUAL ACUITY IMPROVED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD / HUNTINGTON SA60D3 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention