BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3040398 · Received April 3, 2013

    Report

    Report Number
    1119421-2013-00350
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 1, 2012
    Report Date
    March 8, 2013
    Manufacturer
    ALCON -RESEARCH LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE REPORTER TO PROPERLY COMPLETE AN INVESTIGATION. ADD¿L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE HAD A ¿NUMBER¿ OF INTRAOCULAR LENSES (IOLS) WITH GLISTENINGS THAT WERE IMPLANTED IN THE FALL OF 2012. HE SUSPECTS THAT THESE WERE IOLS IN THEIR INVENTORY THAT WERE VERY OLD. ADD¿L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136879 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON -RESEARCH LTD/HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK