BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 569403 · Received January 24, 2005

    Report

    Report Number
    2023826-2005-00124
    Event Type
    Malfunction
    Date Received
    January 24, 2005
    Date of Event
    December 28, 2004
    Report Date
    December 30, 2004
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED AN AQ2010V THREE PIECE SILICONE LENS BUT IT TORE WHILE BEING INSERTED. THE LENS WAS REMOVED IN PIECES WITH NO PT INJURY. THE NURSE STATED IT WAS UNK AS TO WHY THE LENS TORE. AN MSE-PM INJECTOR AND AN AQ2.8S CARTRIDGE WERE USED BUT THE LOT NUMBERS WERE NOT PROVIDED BY THE FACILITY.

    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 UNKNOWN