BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 3074420 · Received April 18, 2013

    Report

    Report Number
    1119279-2013-00127
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDICEL AG
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE LENS WAS REMOVED FROM THE PT'S EYE INTRAOPERATIVELY DUE TO DAMAGE OF THE LENS DURING FOLDING/INSERTION. ANOTHER LENS OF SAME MODEL WAS IMPLANTED SUCCESSFULLY. INCISION WAS ENLARGED BUT NO SUTURE WAS PLACED. THE MOST LIKELY CAUSE OF THE LENS DAMAGE WAS REPORTED AS A LOADING ERROR. NO REPORTED POSTOPERATIVE SEQUELAE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE REF MDR # 1119279-2013-00126 FOR THE INTRAOCULAR LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168344 VISCOJECT 1.8 DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS MEDICEL AG LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other AKREOS MICS INTRAOCULAR LENS (B+L)