BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 18311758 · Received December 12, 2023

    Report

    Report Number
    2023826-2023-05576
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Report Date
    November 28, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H4 (DEVICE MANUFACTURING DATE): NO SERIAL NUMBER REPORTED. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    B5: DUPLICATE EVENT REPORTED IN CLAIM# (B)(4).. THERE IS NO COMPLAINT FOR CLAIM# (B)(4).. 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 POSSIBLE LENS EXCHANGE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694763 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK.