BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1920722 · Received October 29, 2010

    Report

    Report Number
    2023826-2010-01068
    Event Type
    Malfunction
    Date Received
    October 29, 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).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS. THE SURGEON PUSHED DOWN ON THE PLUNGER/INJECTOR TOO FAST. THE PLUNGER GOT HOLD OF THE HAPTIC AND DAMAGED THE LENS. THE LENS WAS PARTIALLY IN THE EYE WHEN THE SURGEON PULLED THE LENS OUT OF THE EYE. LENS WAS STILL PARTIALLY IN THE CARTRIDGE. THERE WAS NO PT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. REPORTER STATED THIS INCIDENT WAS DUE TO SURGEON'S ERROR.

    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 62 YR CARTRIDGE: MODEL -CQ CARTRIDGE-FP -LOT # UNK| INJECTOR: MODEL -MSI-PM -LOT # UNK