BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR CHAMBER INTRAOCULAR LENS

    MDR report key: 27971 · Received October 5, 1995

    Report

    Report Number
    27971
    Event Type
    Injury
    Date Received
    October 5, 1995
    Date of Event
    September 8, 1995
    Report Date
    October 5, 1995
    Manufacturer
    CILCO DIV OF COOPERVISION, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD DEVELOPED PSEUDOPHAKIC BULLOUS KERATOPATHY, RIGHT EYE, POSSIBLY RELATED TO THE IOL. THE ANTERIOR CHAMBER INTRAOCULAR LENS WAS FOUND TO BE DISPLACED ANTERIORLY AND THEREFORE EXPLANTED. A NEW IOL WAS IMPLANTED AND A CORNEAL GRAFT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTERIOR CHAMBER INTRAOCULAR LENS Implant ANTERIOR CHAMBER INTRAOCULAR LENS HQL CILCO DIV OF COOPERVISION, INC. SAC5 A3856A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention