BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACARE TABLETS W/ VIT B-12

    MDR report key: 194624 · Received October 30, 1998

    Report

    Report Number
    2011068-1998-00046
    Event Type
    Injury
    Date Received
    October 30, 1998
    Date of Event
    August 19, 1998
    Report Date
    September 11, 1998
    Manufacturer
    ALLERGAN PHARMACEUTICALS (IRELAND) LTD., INC
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT A 42 YEAR OLD MALE PATIENT EXPERIENCED TOXIC KERATOPATHY AND LOST 90% OF THE CORNEAL EPITHELIUM AFTER USING THE ULTRACARE SYSTEM. THE PATIENT APPARENTLY SOUGHT UNSPECIFIED MEDICAL ATTENTION AT THE TIME OF THE INITIAL REACTION, AND WAS SEEN BY THE REPORTING DOCTOR ONE WEEK LATER. THE REPORTING DOCTOR PRESCRIBED FML AND ARTIFICIAL TEARS. THE PATIENT'S CORRECTED VISION AT THAT TIME WAS 20/50 TO 20/60. PATIENT RECHALLENGED WITH PRODUCT AND EXPERIENCED CONJUNCTIVAL INJECTION. IN FOLLOW-UP WITH THE REPORTING PHYSICIAN, IT WAS NOTED THAT THE PATIENT'S CORNEAS ARE HEALING AND HIS CORRECTED VISION HAS RETURNED TO 20/20. DR. STATED THAT TREATMENT GIVEN WAS TO PRECLUDE PERMANENT INJURY. CORRECTIVE TREATMENT: FML AND ARTIFICIAL TEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACARE TABLETS W/ VIT B-12 CONTACT LENS CARE PRODUCT LPN ALLERGAN PHARMACEUTICALS (IRELAND) LTD., INC NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention CONTACT LENS CARE PRODUCT.| ULTRACARE DISINFECTING SOLUTION, DEVICE TYPE: