BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17515557 · Received August 11, 2023

    Report

    Report Number
    2023826-2023-03422
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    July 19, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLAIM # (B)(4).

    Description of Event or Problem · 0

    A RETROSPECTIVE STUDY WAS FOUND BY STAAR SURGICAL COMPANY. THE STUDY WAS IN REGARD TO "CHANGES IN OCULAR PARAMETERS OF THE CRYSTALLINE LENS AFTER IMPLANTATION OF A COLLAMER LENS". A TOTAL OF 117 EYES OF 117 PATIENTS UNDERWENT V4C ICL MODEL OR V4C TICL MODEL IMPLANTATION BETWEEN (B)(6) 2018. THERE WERE DECREASES IN ALL VERTICAL DISTANCE MEASURES FROM THE CENTRAL CORNEAL ENDOTHELIUM TO THE ANTERIOR AND POSTERIOR CRYSTALLINE LENS CAPSULE. PHAKIC INTRAOCULAR LENS IMPLANTATION RESULTED IN LENS THICKENING AND FORWARD MOVEMENT ON DAY 1 POST-OPERATIVELY, WHICH BECOMES STABLE WITHIN 6 MONTHS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176541 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK.