BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1023787 · Received March 20, 2008

    Report

    Report Number
    2023826-2008-00404
    Event Type
    Other
    Date Received
    March 20, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 20, 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
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT AGAINST THE PRODUCT, LABELED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS AND THE LENS WAS REMOVED, BECAUSE THE SURGEON DECIDED TO USE A DIFFERENT DIOPTER. THE LENS WAS REMOVED WITHOUT ANY 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 CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 STAARVISC II| CARTRIDGE MODEL AQ CARTRIDGE-FP| INJECTOR MODEL MSI-TM