BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2051059 · Received April 5, 2011

    Report

    Report Number
    2023826-2011-00282
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 5, 2011
    Report Date
    March 25, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SECONDARY SURGERY, PIGMENT DISPERSION, IRIS ATROPHY. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS ON (B)(6) 2010 IN PATIENT'S LEFT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE TO PIGMENT DISPERSION AND IRIS ATROPHY. NO OTHER LENS WAS IMPLANTED. IRIS-PUPIL IS GETTING BETTER SLOWLY. PATIENT'S LAST VISIT ON (B)(6) 2011 BCVA 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention CARTRIDGE: MODEL AND LOT NUMBER - UNK| FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK| INJECTOR: MODEL AND LOT NUMBER - UNK