BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1031483 · Received April 18, 2008

    Report

    Report Number
    2023826-2008-00553
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS ADVANCING A THREE PIECE LENS MODEL AQ2010V INTO THE PATIENT'S EYE AND THE PATIENT MOVED THEIR HEAD CAUSING THE LENS TO POP OUT ONTO THE OUTSIDE OF PATIENT'S EYE AND THE LENS WAS CONTAMINATED. THE SURGEON DECIDED NOT TO USE THIS LENS. THERE WAS NO PRODUCT MALFUNCTION OR PATIENT INJURY IT WAS DUE TO A PATIENT EVENT.

    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 AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL CQ CARTRIDGE-FP - LOT NUMBER UNK| INJECTOR MODEL: MSI-TM LOT NUMBER: UNK