BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1952672 · Received January 4, 2011

    Report

    Report Number
    2023826-2011-00004
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 20, 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 AQ2010V THREE PIECE SILICONE LENS. THE LENS TORE UPON INSERTION INTO THE EYE. LENS WAS REMOVED WITH NO PATIENT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. REPORTER STATED THE CAUSE OF LENS TEAR WAS DUE TO LOADING ERROR.

    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 CARTRIDGE MODEL - AQ CARTRIDGE-FP, LOT NUMBER-UNK| INJECTOR MODEL - MSI-PM, LOT NUMBER - UNK