BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1031141 · Received April 18, 2008

    Report

    Report Number
    2023826-2008-00542
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 27, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS AND THE LENS TORE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER SAME TYPE LENS WAS IMPLANTED. SUTURES WERE NOT REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VISCOELASTIC STAARVISC II| CARTRIDGE MODEL CQ CARTRIDGE-FP| INJECTOR MODEL MSI-PM