BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAOCULAR LENS

    MDR report key: 31859 · Received April 8, 1996

    Report

    Report Number
    MW1008826
    Event Type
    Malfunction
    Date Received
    April 8, 1996
    Date of Event
    March 15, 1996
    Report Date
    April 1, 1996
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON PLACING THE POSTERIOR CHAMBER SILICONE LENS INTO THE CAPSULAR BAG, APPROX 1/3 OF THE LENS REMAINED BEHIND IN THE INJECTOR AND 2/3 OF THE LENS WAS DELIVERED INTO THE POSTERIOR CAPSULAR BAG. THE POSTERIOR FRAGMENT WAS LIFTED OUT WITH VISCOELASTIC SURGICAL AID. DUE TO THE MITIGATING CIRCUMSTANCES AND THE ADD'L INTRAOCULAR MANIPULATION THE PHYSICIAN DETERMINED IT WAS NOT PRUDENT TO PROCEED WITH THE ASTIGMATIC KERATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAOCULAR LENS INTRAOCULAR LENS HQL CHIRON VISION CORP. C10UB

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other