BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3163329 · Received June 11, 2013

    Report

    Report Number
    2023826-2013-00464
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    February 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - CATARACT, INDUCED. SIZE INCORRECT FOR PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2010. CORTICAL OPACITY WAS NOTED ON (B)(6) 2013 AND THE LENS WAS EXPLANTED ON (B)(6) 2013 DUE TO LOW VAULTING. CATARACT SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264487 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM115V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK