BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3042184 · Received April 4, 2013

    Report

    Report Number
    1119421-2013-00359
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 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
    TX, 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. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A CLINICAL STUDY PATIENT WITH AN INTRAOCULAR LENS (IOL) THAT ROTATED 20 DEGREES OFF AXIS FOLLOWING IOL IMPLANT SURGERY. IN A FOLLOW-UP, THE CLINICAL SITE MANAGER INDICATED A SECONDARY PROCEDURE WAS PERFORMED TO REPOSITION THE IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139325 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT7 12101142

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention