BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 18007305 · Received October 25, 2023

    Report

    Report Number
    2023826-2023-04778
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 22, 2023
    Report Date
    September 25, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6-INVESTIGATION TYPE 4110: LENS WORK ORDER SEARCH- NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. CLAIM#: (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 12.1MM VTICMO 12.1 IMPLANTABLE COLLAMER LENS OF -11.00/2.0/118 (SPHERE/CYLINDER/AXIS) LENS TEAR/BREAK DURING LOADING. THE LENS WAS NOT IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151868 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 12.1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female CARTRIDGE MODEL: SFC-45: LOT# UNK.| FOAM TIP PLUNGER (FTP), LOT# UNK.| INJECTOR MODEL: MSI-PF, LOT# UNK.