BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON SN60WF

    MDR report key: 2093784 · Received May 11, 2011

    Report

    Report Number
    MW5020591
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED PAIN AND BLURRY VISION 4TH POST OP DAY FOLLOWING CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT. SHE HAD INCREASED INTRAOCULAR PRESSURE AND CORNEAL EDEMA. THE LENS IMPLANT WAS ROTATED INFERIORLY, BUT CAPSULAR BAG WAS NOT COMPROMISED. THE INCREASED PRESSURE WAS TREATED WITH EYE DROPS. SHE FOLLOWED UP THE NEXT DAY AT WHICH TIME, THERE WAS SOME CLEARING OF THE CORNEA AND A THREE MIRROR GONIOSCOPY LENS IMPLANT WAS PLACED ON TO THE CORNEA AND A TRUNCATED HAPTIC WAS NOTED IN THE ANTERIOR CHAMBER ANGLE. AT THIS TIME, THE SURGEON OPTED TO RETURN PT TO OPERATING ROOM FOR EXPLANTATION OF THE AFFECTED LENS AND REPLACEMENT OF THE LENS IMPLANT INTO THE CAPSULAR BAG AGAIN. PT RETURNED TO OPERATING ROOM ON THE 6TH POST OP DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON SN60WF INTRAOCULAR LENS 24.5D HQL ALCON LABORATORIES SN60WF 11068721046

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability