BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 3121962 · Received May 16, 2013

    Report

    Report Number
    2031924-2013-00091
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BAUSCH AND LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    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 DURING INSERTION OF THE LENS INTO THE PATIENT'S EYE, THE TRAILING HAPTIC WAS DAMAGED. THE SURGEON ENLARGED THE INCISION AND REMOVED THE LENS. ANOTHER LENS OF SAME MODEL WAS IMPLANTED SUCCESSFULLY AND SUTURES WERE PLACED. ACCORDING TO THE SURGEON, THE PATIENT'S CURRENT PROGNOSIS IS GOOD. PLEASE REFERENCE MDR # 2031924-2013-00090 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216429 CRYTALSERT CRYSTALENS DELIVERY SYSTEM MSS/ IOL INSERTER/ INJECTOR MSS BAUSCH AND LOMB CI - 28

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other CRYSTALENS ACCOMODATING IOL