BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVUE ADVANCED HYDRAVUE

    MDR report key: 4766600 · Received May 11, 2015

    Report

    Report Number
    1034196-2015-00001
    Event Type
    Injury
    Date Received
    May 11, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 24, 2015
    Manufacturer
    UNILENS CORP., USA
    Product Code
    LPL
    PMA / PMN Number
    K100456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BASED ON THE REPORTING BY THE EYECARE PRACTITIONER, THE ISSUE IS A FITTING ISSUE THAT MAY BE ALLEVIATED BY OBTAINING CONTACT LENSES WITH A DIFFERENT PRESCRIPTION. THE ECP INTENDS TO REFIT THE PATIENT IN THE SAME LENS STYLE (SAME MATERIAL), BUT WITH A DIFFERENT PRESCRIPTION. THE LENSES INVOLVED IN THE ADVERSE EVENT SHOULD BE RETURNED AT THAT TIME AND BE AVAILABLE TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    STERILE PUNCTATE KERATITIS WITH STERILE CORNEAL ULCER. PATIENT RECEIVED TRIAL CONTACT LENSES APPROXIMATELY (B)(6) 2015. AT ONE MONTH FOLLOWUP, EYE CARE PRACTITIONER NOTED 3 TINY CLUSTERS OF STERILE PUNCTATE KERATITIS OS. LENS USE CONTINUED. AT TWO MONTH FOLLOW UP, CLUSTERS WERE LARGER. AT THREE MONTH FOLLOW-UP, THE AREAS WERE MORE EXTENSIVE WITH INFILTRATES, AND A STERILE CORNEAL ULCER WAS PRESENT. A MIRROR IMAGE OF THE SAME CONDITION WAS PRESENT OD. LENS USE WAS DISCONTINUED FOR 4 WEEKS AND THE CONDITION HAS COMPLETELY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308482 CVUE ADVANCED HYDRAVUE SOFT CONTACT LENS, PRODUCT CODE: LPL LPL UNILENS CORP., USA CVUE ADVANCED HYDRAVUE 831490

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other