BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 246297 · Received October 21, 1999

    Report

    Report Number
    1119421-1999-01856
    Event Type
    Other
    Date Received
    October 21, 1999
    Report Date
    September 21, 1999
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO PROVIDED BY THE REPORTING SURGEON INDICATES THAT SMALL HIGH DENSITY BUBBLES(DROPLETS) WHERE NOTED IN THE INTRAOCULAR LENS DURING EXAMINATION. THE RELATIONSHIP OF THIS OBSERVATION WITH THE REPORTED PHOTOOHOBIA THAT OCCURRED DURING SLIT LAMP EXAMINATION IS NOT KNOWN. THE PT IS REPORTED TO BE SATISFIED WITH HIS VISION AND IS NOT AWARE OF THE SURGEON'S OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF Implant INTRAOCULAR LENS HQL ALCON LABORATORIES MA60BM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other