BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIEC

    MDR report key: 669048 · Received January 26, 2006

    Report

    Report Number
    2023826-2006-00110
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Date of Event
    December 19, 2005
    Report Date
    December 28, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON INSERTED A CC4204BF COLLAMER PLATE LENS AND THE LENS TORE. THERE WAS NO PATIENT CONTACT OR INJURY. THIS IS ONE OF THE THREE LENSES THE SURGEON ATTEMPTED TO INSERT INTO THIS PATIENT. SEE MFG REPORT #2023826-2006-00111 AND #2023826-2006-00112.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR