BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1061016 · Received June 13, 2008

    Report

    Report Number
    2023826-2008-00804
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 16, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE LENS IS TORN IN HALF INTO A HAPTIC. 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 A SINGLE PIECE SILICONE LENS MODEL AA4204VF AND THE LENS TORE COMING OUT OF THE INJECTOR. THE SURGEON CUT UP THE LENS TO REMOVE IT, NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL MTC-60CFP LOT#UNK| INJECTOR: MODEL MSI-PR LOT#UNK