BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 2497106 · Received March 13, 2012

    Report

    Report Number
    2023826-2012-00181
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LENS WORK ORDER SEARCH. 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 CC4204A COLLAMER ASPHERIC SINGLE PLATE LENS. A CRACK OR CREASE WAS NOTED IN THE MIDDLE OF THE LENS, WHILE LENS WAS IN THE INJECTOR. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE FACILITY, BUT NONE HAS BEEN FORTHCOMING. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    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 CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR| CARTRIDGE