BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2023826-2023-02348

    MDR report key: 17122144 · Received June 13, 2023

    Report

    Report Number
    2023826-2023-02348
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    February 2, 2023
    Report Date
    June 9, 2023
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4-A6: UNK. CLAIM #(B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -6.5/0.5/006 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. ON (B)(6)2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH/DIFFERENT MODEL LENS DUE TO EXCESSIVE VAULT. REPORTEDLY, "ASTIGMATIC CRYSTALS WERE IMPLANTED FOR THE FIRST TIME. THE PATIENT'S SUPPLY WAS TOO HIGH, AND THE DOCTOR FINALLY ADJUSTED 12.6 IMPLANTATION OF NON-ASTIGMATIC CRYSTALS BECAUSE SUITABLE ASTIGMATIC CRYSTALS COULD NOT BE MATCHED." THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409660 MTA STAAR SURGICAL CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention