BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1051646 · Received May 21, 2008

    Report

    Report Number
    1119421-2008-00323
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED IN THE LOT NUMBER.

    Description of Event or Problem · 1

    A NURSE REPORTED AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE EYE OF A PT AND THERE SEEMED TO BE EXTRA LENS MATERIAL ON THE OPTIC DISC NEAR THE HAPTIC AREA. THE IOL WAS REMOVED AND ANOTHER IOL WAS IMPLANTED. THE PT EXPERIENCED CORNEAL TRAUMA DURING THE SURGERY. THE PT WAS TREATED WITH STEROID DROP THERAPY AND THE EYE WAS REPORTED TO BE "SETTLING DOWN". THE CONDITION OF THE PT WAS REPORTED AS "IMPROVED' FOLLOWING TREATMENT. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN60T3 10723814

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention