BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2051246 · Received April 6, 2011

    Report

    Report Number
    2023826-2011-00296
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    March 14, 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
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - REFRACTIVE SURPRISE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN ICM125V4 12.5MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2010, AND AFTER IMPLANTATION, THEY NOTICED THAT THERE WERE SOME PROBLEMS WITH NEAR VISION. CUSTOMER REPORTED A REFRACTIVE SURPRISE. THE LENS REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention