BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIPLOMATE PHACO MACHINE

    MDR report key: 29927 · Received February 7, 1996

    Report

    Report Number
    MW1008281
    Event Type
    Other
    Date Received
    February 7, 1996
    Date of Event
    August 28, 1995
    Report Date
    January 31, 1996
    Manufacturer
    ALLERGAN MEDICAL OPTICS, INC.
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CATARACT EXTRACTION OF LEFT EYE WITH SMALL INCISION PHACO EMULSIFICATION TECHNIQUE AND IOL INSERTION. PT HAD A SMALL PUPIL AND A HARD NUCLEUS. SURGICAL WOUND CLOSED AND 7-0 STITCH USED. PT SEEN ON 8/29/95, 9/6/95 FOR POST-OP VISITS. ON 9/20/95 MD NOTICED A FOREIGN BODY EMBEDDED IN IRIS AT 8 O'CLOCK. MD HAD NOT PREVIOUSLY NOTICED THIS FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIPLOMATE PHACO MACHINE PHACO EMULSIFICATION MACHINE HQC ALLERGAN MEDICAL OPTICS, INC. 52-01-01-2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other