BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1031484 · Received April 18, 2008

    Report

    Report Number
    2023826-2008-00565
    Event Type
    Other
    Date Received
    April 18, 2008
    Report Date
    March 26, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE LENS OPTIC IS TORN OFF IN HALF AND THE HAPTIC IS TORN OFF INTO THE OPTIC AND IS MISSING. THERE IS REDDISH 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 INSERTED A THREE PIECE SILICONE LENS MODEL AQ2010V WITH NO DAMAGE TO THE LENS OR THE PATIENT BUT DECIDED TO REMOVE THE LENS AND PUT IN A DIFFERENT TYPE OF LENS. THE SURGEON REMOVED THE LENS WITHOUT ENLARGING THE INCISION, HOWEVER, HE DID NOT TEAR THE LENS UPON REMOVING IT. THE SURGEON STATED THAT THERE WAS NO MALFUNCTION OF THE LENS OR PATIENT INJURY.

    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 UNK LOT NUMBER UNK| INJECTOR MODEL: UNK LOT NUMBER: UNK