BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE-PIECE FOLDABLE INTRAOCUL

    MDR report key: 1002708 · Received February 26, 2008

    Report

    Report Number
    2023826-2008-00235
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Report Date
    January 28, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN AA4203TL TORIC SILICONE SINGLE PIECE LENS AND THE PT WAS UNHAPPY BECAUSE HE STILL HAD THE SAME ASTIGMATISM AS BEFORE THE SURGERY. THE REPORTER STATED THE DOCTOR FELT THAT THE LENS DID NOT HAVE ANY CYLINDER. THE LENS REMAINS IMPLANTED.

    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. AA4203TL NA

    Patients

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