BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3011154 · Received March 15, 2013

    Report

    Report Number
    1119421-2013-00272
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. MULTI ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNEXPECTED POSTOPERATIVE OUTCOME FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. HE REPORTED THAT THE CYLINDER AXIS AND AMOUNT OF POSTOPERATIVE CYLINDER WERE NOT EXPECTED. THE CURRENT CYLINDER AXIS ORIENTATION WAS EIGHT DEGREES FROM THE INTENDED AXIS ORIENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110493 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT9 12124187

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other