BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1052919 · Received May 22, 2008

    Report

    Report Number
    2023826-2008-00736
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 7, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND. #416160.

    Description of Event or Problem · 1

    THE REPORTER STATED THE TECHNICIAN NOTED THAT THE LEADING HAPTIC OF THE LENS WAS FOUND TO BE BENT WHEN REMOVED FROM THE LENS TRAY. THE TECHNICIAN ATTEMPTED TO LOAD THE LENS BUT THE LENS WOULD NOT LOAD PROPERLY. THE REPORTER STATED THEY DECIDED NOT TO USE THE LENS AND THERE WAS NO PT CONTACT. THE REPORTER STATED THE LENS WAS RECEIVED WITH A BENT HAPTIC AND WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL AND LOT# UNK| CARTRIDGE MODEL AND LOT # UNK