BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2542686 · Received April 13, 2012

    Report

    Report Number
    1119421-2012-00496
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    February 2, 2012
    Report Date
    March 15, 2012
    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
    PA, 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 LENS MET RELEASE CRITERIA. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFO WAS REQUESTED BY PHONE, FAX AND MAIL ON 03/16/2012. A PARTIALLY COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/16/2012. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE EXPLANTED AN INTRAOCULAR LENS (IOL) SIX WEEKS FOLLOWING IMPLANT SURGERY DUE TO LENS WAS OFF AXIS. THE PT REPORTED HAVING BLURRY VISION. THE REPLACEMENT LENS WAS THE SAME MODEL WITH A DIFFERENT DIOPTER POWER. ADDITIONAL INFO WAS RECEIVED FROM THE SURGEON STATING THAT, IN HIS OPINION, IT WAS UNK IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 11029911

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention MONARCH HANDPIECE| DUOVISC| MONARCH CARTRIDGE