BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEAR COMPATIBLES

    MDR report key: 660459 · Received January 5, 2006

    Report

    Report Number
    1118577-2005-00004
    Event Type
    Injury
    Date Received
    January 5, 2006
    Date of Event
    August 20, 2005
    Report Date
    January 3, 2006
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CO INITIALLY REC'D INITIAL REPORT IN 2005. 08/2005 SUBJECT WAS PREVIOUSLY TREATED AS REPORTED IN THE HOSP REPORT. THE DIAGNOSIS WAS SEVERE KERATITIS WITH CORNEAL ULCER CAUSED BY CONTACT LENS. SUBJECT WAS ADMITTED IN 9/2005. FAILURE TO RESPOND TO TREATMENT. CORNEAL ULCER FOUND TO BE RESISTANT TO TREATMENT AND INDICATION FOR PUNCH BIOPSY WAS MADE. BIOPSY EXAMINED PARTICULARLY FOR ACANTHAMOEBA AND MYCOTA. BOTH NEGATIVE. DURING TREATMENT, AMNIOTIC MEMBRANE WAS REMOVED AS EXAMINATION BY SLIT LAMP NOT POSSIBLE. AT DISCHARGE, VA OD: HAND MOTION, OS, 20/80. INTRAOCULAR PRESSURE (IOP): PALPABLE- NORMAL OU. SLIT LAMP- OD: CONJUNCTIVAL INJECTION, CORNEA DISSEMINATED, STROMA CLOUDY, INFILTRATED DEMARCATED, AC NORMAL AND FREE OF IRRITATION. OD: VITREOUS FREE, CLEAR, RETINA ATTACHED ALL SIDES. TX: LAVASEPT (5X), AMPHO (5X), POLYSPECTRAN (5X), EYE PROTECTION (COVER) AT NIGHT, BOROSCOPOL (3X), AND HYLOCARE (5X) LUBRICANTS. FOLLOW-UP SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCLEAR COMPATIBLES CONTACT LENS - DAILY WEAR LPL COOPERVISION, INC. NA 200510683D

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization