BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIRON VISION

    MDR report key: 218169 · Received April 7, 1999

    Report

    Report Number
    MW1016089
    Event Type
    Injury
    Date Received
    April 7, 1999
    Date of Event
    March 11, 1999
    Report Date
    March 30, 1999
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD AN UNCOMPLICATED PHACOEMULSIFICATION WITH POSTERIOR CHAMBER LENS IMPLANTATION ON 03/11/99. ONE WEEK POST SURGERY HE WAS FOUND TO HAVE EXCESSIVE MYOPIA IN THE LEFT EYE WITH A REFRACTION OF -4.00 SPHERE, +2.00 CYLINDER, AXIS 105. THE PT IS UNCOMFORTABLE WITH THIS AMOUNT OF MYOPIA. THE "A-SCAN" AXIAL LENGTH MEASUREMENT HAS BEEN REVIEWED AND REPEATED. THE KERATOMETRY HAS BEEN REVIEWED AND COMPLETED. THERE IS ESSENTIALLY NO SIGNIFICANT CHANGE IN THE PREVIOUS MEASUREMENTS. THE DOCTOR SUSPECTS THAT THE IOL MIGHT HAVE BEEN IN ERROR FROM THE MFR, BUT THERE IS NO PRACTICAL WAY TO DETERMINE THIS AT THIS POINT. HE HAS BEEN RE-IMPLANTED WITH A SLIGHTLY WEAKER IOL IN ORDER TO IMPROVE HIS REFRACTIVE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIRON VISION Implant INTRAOCULAR LENS HQL CHIRON VISION CORP. LI61U 9828511043

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R