BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1002836 · Received February 26, 2008

    Report

    Report Number
    2023826-2008-00249
    Event Type
    Other
    Date Received
    February 26, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THAT HALF OF THE LENS OPTIC AND A HAPTIC IS TORN OFF AND MISSING. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING A THREE PIECE COLLAMER MODEL CQ2015A AND THE LENS TORE. THE LENS WAS REMOVED AND REPLACED WITH NO PATIENT 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 INJECTOR MODEL: MSI-PM LOT NUMBER: UNK| CARTRIDGE MODEL: CQ CARTRIDGE-FP LOT NUMBER: UNK