BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2921698 · Received January 15, 2013

    Report

    Report Number
    2023826-2013-00046
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    October 12, 2012
    Report Date
    December 24, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN PATIENT'S RIGHT EYE ON (B)(6) 2011. THE LENS WAS EXPLANTED ON 10/12/2012 DUE TO EXCESSIVE VAULT ASSOCIATED WITH ELEVATED INTRAOCULAR PRESSURE. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. ON PATIENT'S LAST VISIT, UCVA WAS 20/20. SEE MFR # 2023826-2013-00047 FOR LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22096 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention