BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 275131 · Received April 24, 2000

    Report

    Report Number
    MW1018748
    Event Type
    Injury
    Date Received
    April 24, 2000
    Date of Event
    April 19, 2000
    Report Date
    April 21, 2000
    Manufacturer
    MEDICAL DEVELOPMENT RESEARCH, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LENS BECOMES CLOUDY. LOCAL DISTRIBUTOR OF INTRAOCULAR LENSES AND EQUIPMENT SINCE 1999 HAS BEEN SENDING MEDWATCH-SHEETS REGARDING THE COMPLAINTS OF SOME CATARACT SURGEONS ABOUT PROBLEMS NOTICED AT IMPLANTED INTRAOCULAR LENSES. THE PT SIGNS WERE VISUAL ABERRATION/OPTICAL PHENOMENA AT THE IOL. THESE OBSERVED PHENOMENA OCCURRED ONLY WITH ONE TYPE OF HYDROPHILIC ACRYLIC IOL OF THE MFR. SEVERAL TIMES RPTR ASKED THIS CO TO INFORM THEM ABOUT THE REASONS FOR THE DESCRIBED COMPLAINTS. UNFORTUNATELY THEY DID NOT WANT TO TELL RPTR THE REASON FOR THESE PRODUCT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * IOL HQL MEDICAL DEVELOPMENT RESEARCH, INC. SC60B-OUV 80402781

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability