BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE

    MDR report key: 731908 · Received June 23, 2006

    Report

    Report Number
    2023826-2006-00858
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 24, 2006
    Report Date
    May 25, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    p990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# P990013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A CQ2015 COLLAMER THREE-PIECE LENS AND ONE HAPTIC TORE OFF. THE LENS WAS REMOVED IN PIECES WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. ANOTHER SAME TYPE LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR CARTRIDGE MODEL CQ CARTRIDGE-FP - LOT NUMBER UNK| INJECTOR MODEL MSI-TM - LOT NUMBER UNK