BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIEC

    MDR report key: 729341 · Received June 16, 2006

    Report

    Report Number
    2023826-2006-00810
    Event Type
    Malfunction
    Date Received
    June 16, 2006
    Date of Event
    May 18, 2006
    Report Date
    May 19, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    p900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. PMA# P900048.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TECHNICIAN OPENED THE LENS TRAY OF AN AQ2010V SILICONE THREE-PIECE LENS AND NOTED THERE WAS A SPOT ON THE LENS. THE LENS WAS NOT USED AND THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIEC INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR