BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 690117 · Received March 20, 2006

    Report

    Report Number
    2023826-2006-00339
    Event Type
    Injury
    Date Received
    March 20, 2006
    Date of Event
    January 25, 2006
    Report Date
    February 22, 2006
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPROTER STATED THE THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN 2006. ON 01/25/2006 DUE TO EXCESSIVE VAULT, NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER THE LENS WAS REMOVED. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH ICL.

    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 33 YR Required Intervention