BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2822455 · Received November 2, 2012

    Report

    Report Number
    1119421-2012-01355
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    May 25, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE NOTED HIGHER RESISTANCE WHILE INJECTING THE LENS. HE APPLIED GREATER PRESSURE TO THE INJECTOR WHICH RESULTED IN THE LENS BEING CATAPULTED INTO THE CAPSULAR BAG. THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE. AN ANTERIOR VITRECTOMY WAS PERFORMED. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT RESOLVED WITH TREATMENT (LENS REPLACEMENT AND VITRECTOMY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention DUCKWORTH KENT INJECTOR| VISCOAT| MONARCH C CARTRIDGE