BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1202139 · Received October 16, 2008

    Report

    Report Number
    2023826-2008-01299
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 24, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A SILICONE THREE PIECE LENS BUT THE HAPTIC TORE WHILE THE LENS WAS ADVANCING. THERE WAS NO PATIENT CONTACT. THE CARTRIDGE USED HAS NOT BEEN APPROVED BY THE MANUFACTURER FOR USE WITH THIS MODEL LENS.

    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. AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR INJECTOR: MODEL MSI-TM| CARTRIDGE: MODEL CQ CARTRIDGE-FP