BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 19081782 · Received April 10, 2024

    Report

    Report Number
    2023826-2024-01546
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Report Date
    March 25, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4-A6:UNK. B3: UNK. D4 (EXPERIATION 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). A SCHEDULED REMOVAL AND REPLACEMENT WAS REPORTED. NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867711 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK.