BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1062455 · Received June 19, 2008

    Report

    Report Number
    2023826-2008-00846
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS ONE HAPTIC IS TORN OFF AND THERE ARE TWO SMALL TEARS IN THE OPTIC OF THE LENS. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING AN ASPHERIC THREE PIECE COLLAMER LENS MODEL CQ2015A AND THE LENS WAS TORN. THE SURGEON REMOVED THE LENS AND REPLACED IT WITH NO PT INJURY. IT WAS REPORTED THAT THE LENS WAS TORN DUE TO A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE MODEL: CQCARTRIDGE-FP LOT#: UNK| INJECTOR MODEL: MSI-TM LOT#: UNK