BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    MDR report key: 1893033 · Received October 28, 2010

    Report

    Report Number
    2031924-2010-00184
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQE
    PMA / PMN Number
    K063331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING PHACOEMULSIFICATION SURGERY USING THE STELLARIS VISION ENHANCEMENT SYSTEM. INTRAOPERATIVELY, THE CAPSULAR BAG RUPTURED; THE PHYSICIAN ATTRIBUTED THE CAPSULE DAMAGE TO ELEVATED POSTERIOR SEGMENT PRESSURE, DISTENDING THE POSTERIOR CAPSULE FORWARD. AN ANTERIOR VITRECTOMY WAS PERFORMED AND A SOFPORT AO LENS WAS PLACED IN THE SULCUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS OPTIMIZED STABILITY VACUUM PACK HQE BAUSCH + LOMB BL5112 U4378

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention