BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17067335 · Received June 5, 2023

    Report

    Report Number
    2023826-2023-02239
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Report Date
    June 5, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4-A6:UNK. B3: UNK. D4 (EXPIRATION DATE); UNK NO SERIAL NUMBER REPORTED. D6A: UNK. H4 (DEVICE MANUFACTURING DATE): NO SERIAL NUMBER REPORTED. CLAIM (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). REPORTEDLY, "PATIENT IS DOING WELL. HOWEVER, VAULT OD IS 79 MICRONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675508 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown