BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSI LOCATOR TINT

    MDR report key: 238358 · Received September 2, 1999

    Report

    Report Number
    2015587-1999-00003
    Event Type
    Injury
    Date Received
    September 2, 1999
    Date of Event
    April 26, 1999
    Report Date
    September 2, 1999
    Manufacturer
    WESLEY JESSEN/PBH LTD.
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 4/26/99, THE PATIENT CLEANED AND INSERTED LENSES (IN THE AM) FOR THE FIRST TIME. WITHIN 1/2 HOUR, NOTICED FOGGY VISION IN THE LEFT EYE. HOWEVER, WAS UNABLE TO REMOVE LENSES UNTIL 3:00PM. AROUND 6:00PM STARTED NOTICING FOGGY VISION AND PAIN IN BOTH EYES, BUT LEFT EYE WAS WORSE. WENT TO EMERGENCY ROOM; DOCTOR PRESCRIBED PAIN MEDICATION AND INSTRUCTED PATIENT TO GO TO THE OPTHALMOLOGIST THE NEXT MORNING. THE PATIENT BEGAN SEEING THE OPTHALMOLOGIST ON 4/27/99. BILATERAL CORNEAL ABRASIONS WERE DIAGNOSED THAT APPEARED TO BE CAUSED BY A CHEMICAL BURN. AS OF 6/11/99, THE PATIENT HAD A SUPERFICIAL CORNEAL SCAR OF THE RIGHT EYE WITH VISION OF 20/70. THE SCAR MAY BE AMENABLE TO EXIMAR LASER AND WILL BE RE-EVALUATED IN THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSI LOCATOR TINT CONTACT LENS LPL WESLEY JESSEN/PBH LTD. NA CJBAT; CKGFN

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention