BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3760904 · Received April 9, 2014

    Report

    Report Number
    1119421-2014-00242
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 12, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER WAS PROVIDED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT A PT PRESENTED WITH AN UNEXPECTED OUTCOME OF RESIDUAL ASTIGMATISM. THE IOL CORRECTED VERY LITTLE ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213277 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH. LTD / HUNTINGTON SN6AT8 12084712

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other