BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INSTRAOCUL

    MDR report key: 1023378 · Received April 2, 2008

    Report

    Report Number
    2023826-2008-00467
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 5, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AQ2003V SILICONE THREE PIECE LENS AND THE PT'S ANATOMY WAS UNABLE TO SUPPORT THE LENS. THE POSTERIOR CAPSULE RUPTURED AND THE LENS WAS REMOVED. THE REPORTED STATED THE PT'S EYE WAS IN POOR CONDITION PRIOR TO SURGERY AND THE INCIDENT WAS NOT RELATED TO THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INSTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE MODEL AQ CARTRIDGE-FP| INJECTOR MODEL MSI-TM