BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1000444 · Received February 21, 2008

    Report

    Report Number
    2023826-2008-00220
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 22, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: A 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 WAS INSERTING A SINGLE PIECE COLLAMER LENS MODEL CC4204BF AND THE PT'S CAPSULE TORE. IT WAS REPORTED THAT THE LENS DID NOT TEAR UPON INSERTION HOWEVER, THE SURGEON CUT UP THE LENS TO REMOVE IT AND PERFORMED A VITRECTOMY AND PUT IN A LENS IN THE SULCUS. THE LENS WAS DISCARDED IN THE OPERATING ROOM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CC4204BF NA

    Patients

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