BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRRUS INTERNATIONAL

    MDR report key: 274017 · Received April 15, 2000

    Report

    Report Number
    MW1018680
    Event Type
    Injury
    Date Received
    April 15, 2000
    Date of Event
    April 12, 2000
    Report Date
    April 15, 2000
    Manufacturer
    MEDICAL DEVELOPMENT RESEARCH, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR HAS IMPLANTED CIRRUS SC 600-2 HYDROPHILIC ACRYLIC INTRAOCULAR LENS IN THIS PT. RPTR NOTICED OPACIFICATION OF THE IOL 22 MOS LATER AND REMOVED LENS. OPACIFICATION OF AN INTRAOCULAR LENS IS A BIG PROBLEM AND RPTR HAS NOT SEEN SUCH A PROBLEM WITH ANY OTHER IOL. RPTR HAS OTHER CASES WITH OPACIFICATION OF THE SAME BRAND IOL BUT DID NOT YET REMOVE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRRUS INTERNATIONAL INTRAOCULAR LENS HQL MEDICAL DEVELOPMENT RESEARCH, INC. SC600-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention| S