BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2895664 · Received January 3, 2013

    Report

    Report Number
    2023826-2013-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 6, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: THE LENS WAS RECEIVED STUCK IN THE CARTRIDGE. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE CARTRIDGE. CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE MICL13.7 IMPLANTABLE COLLAMER LENS FLIPPED UPSIDE DOWN AS THE SURGEON INSERTED IT IN THE EYE. THE LENS WAS REMOVED AND THE BACK UP ICL WAS IMPLANTED WITHOUT ANY PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS LIKELY DUE TO THE LENS NOT BEING PROPERLY ALIGNED IN THE INJECTOR DURING LOADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3200 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.7 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR SFC-45FP CARTRIDGE MODEL, LOT NUMBER 1278733