BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2932225 · Received January 25, 2013

    Report

    Report Number
    1119421-2013-00078
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 28, 2012
    Manufacturer
    ALCON MANUFACTURING, LTD.
    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

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THERE WAS NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AND INVESTIGATION. ADD¿L INFO WAS REQUESTED ON (B)(4) 2012 AND (B)(4) 2013 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH UNCORRECTED ASTIGMATISM FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD¿L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35889 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. SN6AT7 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other