BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 317482 · Received February 22, 2001

    Report

    Report Number
    6000107-2001-00063
    Event Type
    Injury
    Date Received
    February 22, 2001
    Date of Event
    January 26, 2001
    Report Date
    February 9, 2001
    Manufacturer
    BAUSCH & LOMB SURGICAL
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LENS WAS EXPLANTED DUE TO LENS OPACIFICATION AND DECREASE IN VISION.

    Description of Event or Problem · 1

    LENS OPACIFICATION WAS OBSERVED APPROXIMATELY 27 MONTHS POSTOPERATIVE. PATIENT'S VISUAL ACUITY IS FINGER COUNT AT LAST EXAMINATION. LENS REMAINS IMPLANTED IN THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6928 HYDROVIEW INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R