BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1851092 · Received September 29, 2010

    Report

    Report Number
    2023826-2010-00998
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 22, 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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2015A SILICONE ASPHERIC THREE PIECE LENS AND THE LENS CRACKED. THE LENS WAS REMOVED WITH NO PT HARM. A DIFFERENT MODEL LENS WAS IMPLANTED.

    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. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL MSI-PM - LOT NUMBER UNK| CARTRIDGE: MODEL AQ CARTRIDGE-FP LOT UNK