BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8656503 · Received May 30, 2019

    Report

    Report Number
    2023826-2019-00943
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Report Date
    May 8, 2019
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN (B)(4) BUT NOT MARKETED IN THE U.S. WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM # (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD), BACK IN 2003/2004. THE PATIENT WAS EXPERIENCING REFRACTIVE CHANGE OVER TIME AND THE SURGEON WAS PLANNING TO EXPLANT AND EXCHANGE THE LENS. BUT THE SURGEON CHANGED HIS MIND AND DECIDED TO MONITOR THE PATIENT. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448552 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1