BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2040503 · Received March 18, 2011

    Report

    Report Number
    1119421-2011-00292
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THE SAMPLE WAS NOT RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MGMT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A PQR MGR REPORTED A PT WITH POSTERIOR CAPSULE OPACIFICATION (PCO) THREE YRS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL 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 SN6AD3 10728807

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR