BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 598442 · Received April 28, 2005

    Report

    Report Number
    2023826-2005-00506
    Event Type
    Malfunction
    Date Received
    April 28, 2005
    Date of Event
    March 29, 2005
    Report Date
    March 29, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    \HE SURGEON ATTEMPTED TO IMPLANT AN AQ2010V SILICONE THREE PIECE LENS BUT IT BECAME STUCK IN THE CARTRIDGE WHILE BEING EJECTED AND WOULD NOT ADVANCE. THERE WAS NO PT CONTACT OR INJURY. THE NURSE STATED IT WAS UNKNOWN AS TO WHY THE LENS BECOME STUCK. AN MSI-TM INJECTOR AND AN AQ FP CARTRIDGE, LOT NUMBER 1193032 WERE USED BUT THE NURSE WAS UNABLE TO RECALL THE LOT NUMBER 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 UNKNOWN