BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 2971093 · Received February 14, 2013

    Report

    Report Number
    1119279-2013-00045
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WILL NOT BE 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 THE LENS WAS REMOVED INTRAOPERATIVELY DUE TO A PRE-EXISTING HOLE IN THE POSTERIOR CAPSULE THAT WAS DEEMED "TOO LARGE AFTER LENS INSERTION TO THE CONSIDERED APPROPRIATE FOR THIS TYPE OF LENS." THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A THREE-PIECE IOL WAS IMPLANTED. PT'S VISUAL ACUITY IS THE SAME AS BEFORE SURGERY (COUNT FINGERS AT FOUR FEET) DUE TO SEVERE PRE-EXISTING AGE-RELATED MACULAR DEGENERATION (ARMD). PLEASE REFERENCE MDR#: 1119279-2013-00044 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66173 VISCOJECT 1.8 DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS MEDICEL AG LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other AKREOS AO INTRAOCULAR LENS (B+L)