BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 2.2 INSERTER SET

    MDR report key: 2000842 · Received February 17, 2011

    Report

    Report Number
    1119279-2011-00041
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 18, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORDS REVIEW COULD NOT BE PERFORMED AS THE DEVICE LOT NUMBER IS UNK. THE DELIVERY DEVICE WAS NOT RETURNED; THEREFORE, A PRODUCT EVAL COULD NOT BE PERFORMED. ACCORDING TO THE SURGEON, THE ALLEGED HAPTIC DAMAGE WAS LIKELY CAUSED BY A LOADING ERROR.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY OF THE LEFT EYE WITH ATTEMPTED IMPLANTATION OF THE AKREOS MI60LUS INTRAOCULAR LENS USING THE VISCOJECT 2.2 LENS INJECTOR SYSTEM. ACCORDING TO THE SURGEON, THE LENS HAPTIC TORE DURING INJECTION OF THE LENS, CREATING A ROUGH EDGE. THE SURGEON ALSO REPORTS THAT ONCE THE LENS WAS PLACED IN THE CAPSULAR BAG, IT APPEARED TO BE IN PLACE AND WELL CENTERED. HOWEVER, DURING THE IRRIGATION AND ASPIRATION (I/A) PROCESS, THE SURGEON NOTED THAT THE LENS WAS TITLED POSTERIORLY, DUE TO A POSTERIOR CAPSULE TEAR. THE LENS WAS REMOVED INTRAOPERATIVELY AND AN ANTERIOR VITRECTOMY WAS PERFORMED. A DIFFERENT LENS WAS IMPLANTED. PREOPERATIVELY, THE PT'S BEST CORRECTED VISUAL ACUITY (BCVA) OF THE LEFT EYE WAS 20/40. POSTOPERATIVELY, AFTER INTERVENTION, THE PT'S UNCORRECTED VISUAL ACUITY (UCVA) IN THE LEFT EYE IS 20/50. ACCORDING TO THE SURGEON, THE PT HAS ELEVATED INTRAOCULAR PRESSURE AND UVEITIS. REFERENCE MDR # 1119279-2011-00040.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOJECT 2.2 INSERTER SET IOL INSERTER / INJECTOR MSS BAUSCH & LOMB LP604340

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention MI60LUS INTRAOCULAR LENS (B&L)