BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 4196112 · Received October 21, 2014

    Report

    Report Number
    1119421-2014-00840
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    June 25, 2014
    Report Date
    September 24, 2014
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 COMPLAINT REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION PHONE AND FAX. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A LENS WAS EXCHANGED APPROXIMATELY 3 MONTHS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT WAS REPORTED TO HAVE A SMALL PUPIL AND EXPERIENCED POOR AND VISUAL ACUITY. THE LENS HAD POSTERIOR CAPSULAR OPACIFICATION (PCO) AND HAD MALROTATED WITH INADVERTENT SULCUS PLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669281 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT8 12105749

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention