BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNILENS RGP ASPHERE

    MDR report key: 681006 · Received February 23, 2006

    Report

    Report Number
    1034196-2006-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2006
    Date of Event
    January 24, 2006
    Report Date
    February 23, 2006
    Manufacturer
    UNILENS CORP., USA
    Product Code
    HPX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IN 2006, SUBJECT'S EYE BEGAN TO FEEL UNCOMFORTABLE, SO SUBJECT REMOVED LENS, BUT IT CAME OUT IN PIECES. SUBJECT CALLED PHYSICIAN WHO RECOMMENDED PRESENTING AT THE LOCAL HOSP EMERGENCY ROOM. THE SUBJECT WAS SEEN AT THE EMERGENCY ROOM, THE EYE EXAMINED, EYEDROPS WERE PRESCRIBED (TOMBRAMYCIN ATNIBIOTIC), A TETNAUS SHOT WAS ADMINISTERED, AND THE PT DISCHARGED. THE DIAGNOSTIC AT THE EMERGENCY ROOM WAS A CORNEAL ABRASION AT 9 O'CLOCK AND A SECOND LESSER CORNEAL ABRASION AT 6 O'CLOCK. THE SUBJECT CONTACTED THE MANUFACTURER WHEN SHE WAS UNABLE TO CONTACT HER EYE CARE PROFESSIONAL. SHE WAS ADVISED TO FOLLOW THE CARE INSTRUCTIONS FROM THE EMERGENCY ROOM AND CONTINUE TO CONTACT HER EYECARE PROFESSIONAL. SHE FELT HER EYE WAS 'BETTER' AT THAT TIME. THE SUBJECT'S EYECARE PROFESSIONAL WAS CONTACTED BY THE MANUFACTURER AND WAS REQUESTED TO PROVIDE A PROGNOSIS WHENT HE PT COULD BE SEEN. AS OF 23 FEB 2006, THE PT HAD NOT RETURNED TO THE EYECARE PROFESSIONAL'S OFFICE DUE TO LINGERING FAMILY ILLNESS. NO RESULTS HAVE BEEN FORWARDED FROM THE EYECARE PROFESSIONAL TO THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNILENS RGP ASPHERE RIGID GAS PERMEABLE CONTACT LENS HPX UNILENS CORP., USA UNILESN RGP ASPHERE 700932

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other