BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THRER PIECE FOLDABLE INTRAOCULA

    MDR report key: 1022543 · Received March 27, 2008

    Report

    Report Number
    2023826-2008-00447
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON HAD IMPLANTED AN ASPHERIC COLLAMER LENS MODEL CQ2015A WITH NO LENS DAMAGE OR PT INJURY HOWEVER, THE SURGEON DECIDED TO REMOVE THE LENS AND PUT IN A DIFFERENT MODEL LENS. THE REPORTER STATED THAT THERE WAS NO PRODUCT MALFUNCTION OR PT INJURY. IT WAS DUE TO A SURGEON'S CHOICE. THE LENS WAS DISCARDED IN THE OR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL: UNK| CARTRIDGE MODEL: UNK