BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIROFLEX UV-ABSORBING SILICONE LENS

    MDR report key: 37655 · Received September 5, 1996

    Report

    Report Number
    2027189-1996-00005
    Event Type
    Injury
    Date Received
    September 5, 1996
    Date of Event
    August 6, 1996
    Report Date
    September 5, 1996
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    F10: PATIENT CODE - 2200 (OTHER), INCISION ENLARGMENT, UNLABLED. F10: DEVICE CODE - 1070, BUBBLE, UNLABELED. H3: EVALUATION RESULTS - THE LENS OPTIC WAS SPLIT IN FOUR PLACES ON THE POSTERIOR SURFACE. ONE OF THE SPLITS APPEARED TO BE REFLECTIVE IN NATURE, WHICH MIGHT EXPLAIN THE OBSERVATION OF A PIT OR BUBBLE IN THE CENTER OF THE LENS.

    Description of Event or Problem · 1

    SURGEON INSERTED LENS IN PT'S EYE AND NOTED WHAT APPEARED TO BE A BUBBLE OR PIT IN THE CENTER OF THE LENS. THE INCISION WAS ENLARGED FOR REMOVAL OF THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIROFLEX UV-ABSORBING SILICONE LENS Implant LENS, INTRAOCULAR HQL CHIRON VISION CORP. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention