BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 603495 · Received May 11, 2005

    Report

    Report Number
    2023826-2005-00579
    Event Type
    Malfunction
    Date Received
    May 11, 2005
    Date of Event
    April 4, 2005
    Report Date
    April 14, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SURGEON IMPLANTED A 3-PIECE SILICONE LENS MODEL AQ2010V AND WAS TORN UPON INSERTION. THE LENS WAS IMPLANTED AND REMOVED WITHOUT PT INJURY. IT WAS INDICATED THE AQ CARTRIDGE, LOT NUMBER 1191209, WAS USED. THE CONTACT COULD NOT RECALL THE MODEL AND LOT NUMBERS OF THE INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR