BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3198669 · Received June 25, 2013

    Report

    Report Number
    1119279-2013-00207
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE HAS BEEN REQUESTED BUT NOT RETURNED TO B+L FOR EVAL. 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 DURING IOL INSERTION THE PT'S CAPSULE RUPTURED. A LOSS OF VITREOUS WAS REPORTED AND A VITRECTOMY WAS PERFORMED AND REPLACED WITH AN ANTERIOR CHAMBER IOL. ACCORDING TO THE SURGEON THE CAUSE OF THE EVENT WAS RELATED TO AN UNSTABLE CAPSULE DUE TO PSEUDOEXFOLIATION. PLEASE REFERENCE MDR#: 1119279-2013-00206 FOR THE INTRAOCULAR LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287851 VISCOJECT 1.8 DELIVERY SYSTEM MSS/FOLDERS AND INJECTOR IOL MSS MEDICEL AG LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other AKREOS MICRO INCISION LENS (B+L)