BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1851086 · Received September 28, 2010

    Report

    Report Number
    2023826-2010-00943
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 3, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2003V SILICONE THREE PIECE LENS AND THE LENS OPTIC TORE. THE LENS WAS REMOVED WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES. THE BACKUP LENS WAS IMPLANTED. THIS IS ONE OF TWO LENSES USED ON THIS PT - SEE MFR. REPORT # 2023826-2010-00942.

    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 56 YR INJECTOR: MODEL MSI-PM - LOT NUMBER UNK| CARTRIDGE: MODEL AQ CARTRIDGE-FP - LOT NUMBER UNK