BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 3820786 · Received May 8, 2014

    Report

    Report Number
    1119421-2014-00328
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ALCON RESEARCH . LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS RETURNED. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOB BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A LENS WAS EXCHANGED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279687 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH . LTD/HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention