BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3223733 · Received July 10, 2013

    Report

    Report Number
    1119421-2013-00736
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    April 11, 2013
    Report Date
    June 12, 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
    SD, 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. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. NO FURTHER ACTION IS WARRANTED AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED FOR A CLINICAL STUDY PATIENT THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHO WAS BILATERALLY IMPLANTED, THAT THE LENS ROTATED 33 DEGREES FOR UNKNOWN REASONS. AN IOL REPOSITIONING PROCEDURE WAS PERFORMED. ADDITIONAL INFORMATION IS NOT EXPECTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316030 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT8 12172783

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention