BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1033600 · Received April 24, 2008

    Report

    Report Number
    2023826-2008-00569
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 28, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AA4204VL SILICONE PLATE LENS AND THE PT'S CAPSULE WAS TORN. THE LENS WAS REMOVED AND A ANTERIOR VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4204VL NA

    Patients

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