BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIC LENS

    MDR report key: 582718 · Received March 10, 2005

    Report

    Report Number
    2023826-2005-00314
    Event Type
    Malfunction
    Date Received
    March 10, 2005
    Date of Event
    February 15, 2005
    Report Date
    February 16, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A PLATE SILICONE LENS MODEL AA4204VF AND WAS TORN DURING IMPLANTATION. THE LENS WAS IMPLANTED AND REMOVED WITHOUT PT INJURY. AN MTC=60C CARTRIDGE, LOT NUMBER 1192189, WAS USED DURING SURGERY. THE MODEL AND LOT NUMBERS OF THE INJECTOR ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC LENS INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR