BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3182225 · Received June 14, 2013

    Report

    Report Number
    1119279-2013-00194
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TORN LENS HAPTIC WAS NOTICED AFTER INSERTION. THE LENS WAS REMOVED INTRA-OPERATIVELY AND SAME MODEL LENS WAS SUCCESSFULLY IMPLANTED. THE INCISION WAS NOT ENLARGED, BUT SUTURES WERE USED. THE SURGEON INDICATED THAT IN HIS OPINION THE MOST LIKELY CAUSE OF THE IOL DAMAGE WAS DUE TO FOAM TIP PLUNGER/OVERODE IOL. THE PT'S CURRENT PROGNOSIS AND TREATMENT IS: "ROUTINE CARE - UNCOMPLICATED." PLEASE REF MDR #: 1119279-2013-00193 FOR THE INTRAOCULAR LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271615 VISCOJECT 1.8 DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS MEDICEL AG LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other AKREOS AO INTRAOCULAR LENS (B+L)