BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1012949 · Received March 13, 2008

    Report

    Report Number
    1119421-2008-00131
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 12, 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 Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A HAPTIC DETACHED ONCE THE LENS WAS IN THE CAPSULAR BAG, RESULTING IN A CAPSULAR TEAR WITH VITREOUS LOSS. THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED. DURING THE PROCEDURE, THE PATIENT EXPERIENCED AN INCREASE IN INTRAOCULAR PRESSURE (IOP). POSTOPERATIVELY, THE PATIENT EXPERIENCED DECREASED VISUAL ACUITY, CORNEAL EDEMA AND MACULAR EDEMA. THE SURGEON REPORTS OUTCOME AS EVENTS AS "POOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON MA60AC 10736582

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention PROVISC