BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 10163013 · Received June 17, 2020

    Report

    Report Number
    2023826-2020-01257
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Report Date
    May 26, 2020
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5 - IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED REFRACTIVE CHANGE OVER TIME ("VISION STARTED CHANGING"). CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6 - SHOULD BE CORRECTED TO "H6 - LENS WORK ORDER SEARCH: ONE SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT", IN INITIAL MEDWATCH REPORT. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN THE US. NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.0MM ICM120V4, -09.0, IMPLANTABLE COLLAMER LENS INTO PATIENT'S LEFT EYE (OS) IN 2009. REPORTEDLY, LENS "HAS ROTATED." LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629204 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG ICM120V4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1