BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1014122 · Received March 13, 2008

    Report

    Report Number
    2023826-2008-00318
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    November 18, 2007
    Report Date
    February 27, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN 2007. THE LENS WAS EXPLANTED IN 2007, DUE TO A REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED WITH A DIFFERENT DIOPTER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL CO. ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK