BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2875300 · Received December 13, 2012

    Report

    Report Number
    2023826-2012-00959
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    September 24, 2012
    Report Date
    November 14, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    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 RPTR STATED THE SURGEON IMPLANTED AN 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN PT'S RIGHT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2012, DUE TO LOW VAULT. THE LENS WAS EXCHANGE FOR A LONGER LENGTH LENS. PT'S LAST VISIT ON (B)(6) 2012, UCVA WAS 20/22.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention