BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1031482 · Received April 18, 2008

    Report

    Report Number
    2023826-2008-00550
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 21, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING A THREE PIECE COLLAMER LENS MODEL CQ2015A AND THE LENS TORE. THE SURGEON REMOVED THE LENS WITH NO PATIENT INJURY. THE REPORTER STATED THAT THE LENS WAS TORN DURING LOADING DUE TO A TECHNICAL ERROR.

    Devices

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

    Patients

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