BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8254867 · Received January 16, 2019

    Report

    Report Number
    2023826-2019-00093
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    October 8, 2018
    Report Date
    December 20, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DIOPTER CORRECTED TO " -16.50/+3.5/108 (SPHERE/CYLINDER/AXIS) " COMMON DEVICE NAME: CORRECTED TO: PHAKIC TORIC INTRAOCULAR LENS, PRODUCT CODE: QCB CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S.; (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -16.5/+3.5/180 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE SURGEON NOTES EXCESSIVE VAULTING. REPORTEDLY, THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46781 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR