BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE

    MDR report key: 726341 · Received June 15, 2006

    Report

    Report Number
    2023826-2006-00806
    Event Type
    Injury
    Date Received
    June 15, 2006
    Date of Event
    April 5, 2006
    Report Date
    May 17, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    p900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6 EVALUATION A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS A PORTION OF THE OPTIC AND A HAPTIC IS TORN OFF & THE HAPTIC IS MISSING. THE OTHER HAPTIC IS TORN OFF. CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION PMA/ P900048

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED A THREE PIECE SILICONE LENS MODEL AQ2010V INTO PATIENT'S EYE AND THE HAPTIC TORE OFF. THE SURGEON ENLARGED THE INCIDISON TO REMOVE THE LENS AND REPLACED IT WITH ANOTHER LENS MODEL. A SUTURE WAS USED TO CLOSE THE WOUND. THE REPORTER STATED THAT THE LENS HAPTIC GOT DAMAGED DUE TO THE LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER THREE PIECE INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention INJECTOR MODEL MSI-PM LOT NUMBER UNK| CARTRIDGE MODEL AQ CARTRIDGE-FP LOT NUMBER UNK