BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1032960 · Received April 22, 2008

    Report

    Report Number
    2023826-2008-00576
    Event Type
    Other
    Date Received
    April 22, 2008
    Report Date
    April 11, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT AN AQ2010V SILICONE THREE PIECE LENS BUT THE LENS WAS LOADED IMPROPERLY. THERE WAS PT CONTACT BUT NO INJURY. SUTURES WERE NOT REQUIRED. ADD'L INFO HAS BEEN REQUESTED FROM THE FACILITY BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAIL, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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 CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK