BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2470520 · Received February 24, 2012

    Report

    Report Number
    1119421-2012-00255
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 25, 2012
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    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 ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THE 16 DIOPTER POWER LENS WITH CYLINDER CORRECTION OF 2.25 DIOPTERS WAS EXCHANGED FOR A 14 DIOPTER POWER LENS WITH NO CYLINDER CORRECTION. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. ADD'L INFO REQUESTED BY PHONE, FAX AND MAIL ON 1/30/2012, 2/14/2012, 2/20/2012 AND 2/22/2012. ADD'L INFO WAS RECEIVED ON 2/22/2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE OUTCOME FOLLOWING INTRAOCULAR LENS, (IOL) IMPLANT SURGERY. IN A F/U, THE SURGICAL COORD STATED THE IOL WAS EXCHANGED WITH A DIFFERENT MODEL AND POWER. SHE ALSO STATED THE PT HAS DRY EYE ISSUES AND THE SURGEON FELT THIS COULD HAVE CONTRIBUTED TO THE EVENT, BUT HE WAS UNCERTAIN. THE PT IS DOING WELL FOLLOWING THE IOL EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN6AT4 12037149

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention