BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2190898 · Received July 28, 2011

    Report

    Report Number
    1119421-2011-00937
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED, THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS, THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 06/30/2011 AND 07/01/2011 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/06/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS SUDDENLY RELEASED INTO THE EYE IN A VERY ABRUPT MANNER. THIS CAUSED THE LENS TO IMPACT THE IRIS WITH SIGNIFICANT FORCE CAUSING THE IRIS TO BEGIN BLEEDING. IN A FOLLOW UP WITH THE SURGEON, HE REPORTED, THE LENS CAME OUT AT AN ANGLE AND CAUSED THE IRIS BLEED. HE COULD NOT TELL IF THERE WAS AN IRIS TEAR OR ANY OBVIOUS TRAUMA. THE SURGEON USED MEDICATIONS TO STOP THE BLEEDING. THE SURGEON REPORTED, THE PT IS DOING WELL WITH AN UNCORRECTED VISUAL ACUITY OF 20/40-50 ON THE FIRST POSTOPERATIVE DAY. THE SURGEON INDICATED, THE PT WILL BE PLACED ON A LONGER PERIOD OF POSTOPERATIVE MEDICATIONS. IN A FOLLOW UP, THE SURGEON INDICATED THE EVENT RESOLVED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD. / HUNTINGTON NA 12008833

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VISCOAT| PROVISC