BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1903086 · Received November 15, 2010

    Report

    Report Number
    2023826-2010-01145
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (FOREIGN CONTAMINANT IN LENS VIAL): METHOD: LENS WORK ORDER SEARCH. RESULTS - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPTED TO USE A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS. WHEN THE FLUID WAS POURED OUT OF THE VIAL, THERE WERE PARTICLES IN THE FLUID AND ON THE LENS. LENS WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015A NA

    Patients

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