BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF TORIC

    MDR report key: 3040432 · Received April 3, 2013

    Report

    Report Number
    1119421-2013-00348
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 1, 2012
    Report Date
    March 8, 2013
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE REPORTER TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE HAD A "NUMBER" OF INTRAOCULAR LENS (IOLS) WITH GLISTENINGS THAT WERE IMPLANTED IN THE FALL OF 2012. HE SUSPECTS THAT THESE WERE IOLS IN THEIR INVENTORY THAT WERE VERY OLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135929 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK