BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1031386 · Received April 18, 2008

    Report

    Report Number
    2023826-2008-00560
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    June 5, 2007
    Report Date
    March 25, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: - A LENS SERIAL WORK ORDER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND NO SIMILAR COMPLAINTS WERE FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON NOTICED A FOREIGN OBJECT IN A ONE PIECE COLLAMER LENS MODEL CQ2015 VIAL UPON OPENING IT. THE SURGEON DID NOT USE THE LENS. NO PATIENT CONTACT.

    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 CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1