BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 4132660 · Received September 24, 2014

    Report

    Report Number
    1119421-2014-00741
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND EMAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT HAD AN UNEXPECTED POSTOPERATIVE REFRACTION AND THE LENS WAS NOT AT THE INTENDED ORIENTATION. THE TARGET WAS PLANO AND THE OUTCOME WAS +1.75 -4.00X27. THE INTENDED ORIENTATION WAS 86 DEGREES AND THE POSTOPERATIVE ORIENTATION WAS 57 DEGREES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595601 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN6AT9 12238547

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other